Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-09 @ 9:19 AM
Study NCT ID:
NCT01381094
Status:
COMPLETED
Last Update Posted:
2022-07-01
First Post:
2011-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624313', 'term': 'vadadustat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trials@akebia.com', 'phone': '+1 617-844-6128', 'title': 'Akebia Therapeutics, Inc.', 'organization': 'Akebia Therapeutics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 8 (Follow-up Visit 2 weeks after last dose)', 'description': "Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.", 'eventGroups': [{'id': 'EG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 9, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 5, 'seriousNumAtRisk': 18, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 8, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 11, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 11, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Ear haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Wound infection pseudomonas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Transferrin saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Vitamin d deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Hair texture abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.0'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac pacemaker replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.46', 'spread': '0.792', 'groupId': 'OG000'}, {'value': '9.93', 'spread': '0.643', 'groupId': 'OG001'}, {'value': '9.86', 'spread': '0.606', 'groupId': 'OG002'}, {'value': '9.67', 'spread': '0.796', 'groupId': 'OG003'}, {'value': '9.83', 'spread': '0.677', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.665', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.623', 'groupId': 'OG001'}, {'value': '1.25', 'spread': '0.644', 'groupId': 'OG002'}, {'value': '1.43', 'spread': '0.668', 'groupId': 'OG003'}, {'value': '-0.03', 'spread': '0.649', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.24', 'ciUpperLimit': '1.35', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.20', 'ciUpperLimit': '1.33', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.83', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '0.91', 'ciUpperLimit': '2.00', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'Absolute change from Baseline was calculated as the Week 6 (end of treatment) value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing. If there was only one measurement prior to dosing, this measurement served as Baseline. A positive change from Baseline indicated that hemoglobin concentration increased.', 'unitOfMeasure': 'Grams per deciliter (g/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (MITT) population: All randomized participants who received at least one dose of study medication and had a Baseline (both Screening and Baseline for Hgb and red blood cells \\[RBC\\] count) and at least one post-baseline measurement. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.46', 'spread': '0.792', 'groupId': 'OG000'}, {'value': '9.93', 'spread': '0.643', 'groupId': 'OG001'}, {'value': '9.86', 'spread': '0.606', 'groupId': 'OG002'}, {'value': '9.67', 'spread': '0.796', 'groupId': 'OG003'}, {'value': '9.83', 'spread': '0.677', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.559', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.452', 'groupId': 'OG001'}, {'value': '0.28', 'spread': '0.439', 'groupId': 'OG002'}, {'value': '0.29', 'spread': '0.622', 'groupId': 'OG003'}, {'value': '0.04', 'spread': '0.531', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.575', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.590', 'groupId': 'OG001'}, {'value': '0.54', 'spread': '0.586', 'groupId': 'OG002'}, {'value': '0.53', 'spread': '0.455', 'groupId': 'OG003'}, {'value': '0.14', 'spread': '0.654', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.659', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.605', 'groupId': 'OG001'}, {'value': '0.85', 'spread': '0.650', 'groupId': 'OG002'}, {'value': '1.06', 'spread': '0.900', 'groupId': 'OG003'}, {'value': '0.08', 'spread': '0.613', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.665', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.623', 'groupId': 'OG001'}, {'value': '1.25', 'spread': '0.644', 'groupId': 'OG002'}, {'value': '1.43', 'spread': '0.668', 'groupId': 'OG003'}, {'value': '-0.03', 'spread': '0.649', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.685', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.553', 'groupId': 'OG001'}, {'value': '1.04', 'spread': '0.848', 'groupId': 'OG002'}, {'value': '1.01', 'spread': '0.872', 'groupId': 'OG003'}, {'value': '0.06', 'spread': '0.877', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '=0.9355', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.6594', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0203', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0369', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.3713', 'groupIds': ['OG004'], 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.', 'nonInferiorityComment': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).'}, {'pValue': '=0.1630', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.7615', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0040', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0003', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.3978', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0083', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0323', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0003', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.4230', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0023', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0009', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.5291', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0002', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0222', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0002', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0002', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.9314', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that hemoglobin concentration increased.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '29.0', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '29.6', 'spread': '2.45', 'groupId': 'OG001'}, {'value': '30.4', 'spread': '2.41', 'groupId': 'OG002'}, {'value': '29.6', 'spread': '3.68', 'groupId': 'OG003'}, {'value': '29.8', 'spread': '1.96', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.87', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.25', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '2.65', 'groupId': 'OG003'}, {'value': '0.2', 'spread': '1.70', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.59', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '2.33', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '2.04', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '2.06', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.67', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '2.59', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '3.52', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '2.34', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.46', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '2.47', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '2.74', 'groupId': 'OG003'}, {'value': '-0.4', 'spread': '2.40', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.90', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '2.62', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '3.44', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '2.78', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '=0.5219', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.6743', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0078', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0301', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.4502', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.6967', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.7385', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0176', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0057', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.5551', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0086', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.2385', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0007', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0002', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.8895', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0127', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0076', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0007', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.5522', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0031', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.2188', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0054', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0037', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.9521', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline HCT was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated HCT concentration increased.', 'unitOfMeasure': 'Percentage of red blood cells in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Red Blood Cell (RBC) Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.21', 'spread': '0.415', 'groupId': 'OG000'}, {'value': '3.38', 'spread': '0.286', 'groupId': 'OG001'}, {'value': '3.37', 'spread': '0.286', 'groupId': 'OG002'}, {'value': '3.25', 'spread': '0.366', 'groupId': 'OG003'}, {'value': '3.34', 'spread': '0.463', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.185', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.178', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '0.187', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.227', 'groupId': 'OG003'}, {'value': '-0.02', 'spread': '0.231', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.183', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.186', 'groupId': 'OG001'}, {'value': '0.14', 'spread': '0.229', 'groupId': 'OG002'}, {'value': '0.11', 'spread': '0.172', 'groupId': 'OG003'}, {'value': '0.03', 'spread': '0.281', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.213', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.202', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '0.251', 'groupId': 'OG002'}, {'value': '0.27', 'spread': '0.294', 'groupId': 'OG003'}, {'value': '0.02', 'spread': '0.229', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.243', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.273', 'groupId': 'OG001'}, {'value': '0.39', 'spread': '0.252', 'groupId': 'OG002'}, {'value': '0.41', 'spread': '0.243', 'groupId': 'OG003'}, {'value': '-0.02', 'spread': '0.223', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.242', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.199', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '0.248', 'groupId': 'OG002'}, {'value': '0.26', 'spread': '0.273', 'groupId': 'OG003'}, {'value': '0.01', 'spread': '0.290', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '=0.3943', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.2096', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0637', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.5016', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.7549', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.5991', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.4258', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0336', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0258', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.2412', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0031', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.7705', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0024', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0006', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.6189', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0075', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0259', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.8898', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0010', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.2864', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0002', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0016', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.9697', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline RBC count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated RBC count increased.', 'unitOfMeasure': '10^6 cells/microliter (10^6 cells/μL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0766', 'spread': '0.02855', 'groupId': 'OG000'}, {'value': '0.0569', 'spread': '0.01891', 'groupId': 'OG001'}, {'value': '0.0811', 'spread': '0.01993', 'groupId': 'OG002'}, {'value': '0.0674', 'spread': '0.02715', 'groupId': 'OG003'}, {'value': '0.0700', 'spread': '0.03319', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0022', 'spread': '0.01279', 'groupId': 'OG000'}, {'value': '0.0134', 'spread': '0.01733', 'groupId': 'OG001'}, {'value': '0.0259', 'spread': '0.02223', 'groupId': 'OG002'}, {'value': '0.0289', 'spread': '0.03152', 'groupId': 'OG003'}, {'value': '0.0010', 'spread': '0.01677', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0012', 'spread': '0.01505', 'groupId': 'OG000'}, {'value': '0.0196', 'spread': '0.01919', 'groupId': 'OG001'}, {'value': '0.0346', 'spread': '0.01997', 'groupId': 'OG002'}, {'value': '0.0292', 'spread': '0.01625', 'groupId': 'OG003'}, {'value': '-0.0015', 'spread': '0.01091', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0029', 'spread': '0.01181', 'groupId': 'OG000'}, {'value': '0.0128', 'spread': '0.01586', 'groupId': 'OG001'}, {'value': '0.0234', 'spread': '0.02685', 'groupId': 'OG002'}, {'value': '0.0206', 'spread': '0.02369', 'groupId': 'OG003'}, {'value': '-0.0023', 'spread': '0.01636', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.0020', 'spread': '0.01736', 'groupId': 'OG000'}, {'value': '0.0116', 'spread': '0.02390', 'groupId': 'OG001'}, {'value': '0.0061', 'spread': '0.02217', 'groupId': 'OG002'}, {'value': '0.0047', 'spread': '0.02639', 'groupId': 'OG003'}, {'value': '-0.0004', 'spread': '0.01788', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.0042', 'spread': '0.01900', 'groupId': 'OG000'}, {'value': '0.0015', 'spread': '0.02616', 'groupId': 'OG001'}, {'value': '-0.0152', 'spread': '0.01467', 'groupId': 'OG002'}, {'value': '-0.0119', 'spread': '0.02494', 'groupId': 'OG003'}, {'value': '-0.0035', 'spread': '0.01522', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '=1.0000', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0055', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0009', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0002', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.9722', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 1).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=1.0000', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0008', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0002', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.6579', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.4102', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0023', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0052', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0017', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.7378', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.3371', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0916', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.4656', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.1629', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.7032', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.5194', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.8516', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0017', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0656', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.6495', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Reticulocyte count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated reticulocyte count increased.', 'unitOfMeasure': '10^6 cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Reticulocyte Hgb Content at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '31.02', 'spread': '2.945', 'groupId': 'OG000'}, {'value': '31.44', 'spread': '2.257', 'groupId': 'OG001'}, {'value': '30.26', 'spread': '2.605', 'groupId': 'OG002'}, {'value': '31.54', 'spread': '2.575', 'groupId': 'OG003'}, {'value': '30.73', 'spread': '2.634', 'groupId': 'OG004'}]}]}, {'title': 'Change From Baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.971', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.742', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.964', 'groupId': 'OG002'}, {'value': '0.15', 'spread': '1.214', 'groupId': 'OG003'}, {'value': '0.03', 'spread': '1.104', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '=0.2065', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.1807', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.7869', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.4743', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.6407', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'Change from Baseline was calculated as the Week 6 value minus the Baseline value. Baseline Reticulocyte count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated reticulocyte Hgb content increased.', 'unitOfMeasure': 'Picogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Maximum Change From Baseline in Hgb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.46', 'spread': '0.792', 'groupId': 'OG000'}, {'value': '9.93', 'spread': '0.643', 'groupId': 'OG001'}, {'value': '9.86', 'spread': '0.606', 'groupId': 'OG002'}, {'value': '9.67', 'spread': '0.796', 'groupId': 'OG003'}, {'value': '9.83', 'spread': '0.677', 'groupId': 'OG004'}]}]}, {'title': 'Maximum change from Baseline (up to Week 8)', 'categories': [{'measurements': [{'value': '1.04', 'spread': '0.585', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.581', 'groupId': 'OG001'}, {'value': '1.44', 'spread': '0.675', 'groupId': 'OG002'}, {'value': '1.54', 'spread': '0.911', 'groupId': 'OG003'}, {'value': '0.59', 'spread': '0.568', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0002', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; up to Week 8', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that hemoglobin concentration increased.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Maximum Change From Baseline in HCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '29.0', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '29.6', 'spread': '2.45', 'groupId': 'OG001'}, {'value': '30.4', 'spread': '2.41', 'groupId': 'OG002'}, {'value': '29.6', 'spread': '3.68', 'groupId': 'OG003'}, {'value': '29.8', 'spread': '1.96', 'groupId': 'OG004'}]}]}, {'title': 'Maximum change from Baseline (up to Week 8)', 'categories': [{'measurements': [{'value': '2.94', 'spread': '2.578', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '2.097', 'groupId': 'OG001'}, {'value': '4.43', 'spread': '2.277', 'groupId': 'OG002'}, {'value': '4.84', 'spread': '3.452', 'groupId': 'OG003'}, {'value': '1.89', 'spread': '1.729', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '=0.0002', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0004', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0002', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0002', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; up to Week 8', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline HCT was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that HCT concentration increased.', 'unitOfMeasure': 'Percentage of red blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Maximum Change From Baseline in RBC Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.21', 'spread': '0.415', 'groupId': 'OG000'}, {'value': '3.38', 'spread': '0.286', 'groupId': 'OG001'}, {'value': '3.37', 'spread': '0.286', 'groupId': 'OG002'}, {'value': '3.25', 'spread': '0.366', 'groupId': 'OG003'}, {'value': '3.34', 'spread': '0.463', 'groupId': 'OG004'}]}]}, {'title': 'Maximum change from Baseline (up to Week 8)', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.210', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.239', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '0.249', 'groupId': 'OG002'}, {'value': '0.44', 'spread': '0.291', 'groupId': 'OG003'}, {'value': '0.18', 'spread': '0.183', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0043', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0001', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; up to Week 8', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline RBC Count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that RBC count increased.', 'unitOfMeasure': '10^6 cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Maximum Change in Absolute Reticulocyte Count From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.0766', 'spread': '0.02855', 'groupId': 'OG000'}, {'value': '0.0569', 'spread': '0.01891', 'groupId': 'OG001'}, {'value': '0.0811', 'spread': '0.01993', 'groupId': 'OG002'}, {'value': '0.0674', 'spread': '0.02715', 'groupId': 'OG003'}, {'value': '0.0700', 'spread': '0.03319', 'groupId': 'OG004'}]}]}, {'title': 'Maximum Change from Baseline (up to Week 8)', 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.0145', 'groupId': 'OG000'}, {'value': '0.028', 'spread': '0.0184', 'groupId': 'OG001'}, {'value': '0.040', 'spread': '0.0200', 'groupId': 'OG002'}, {'value': '0.042', 'spread': '0.0263', 'groupId': 'OG003'}, {'value': '0.011', 'spread': '0.0129', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '=0.0027', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0001', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0005', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group.', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; up to Week 8', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline absolute reticulocyte count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that reticulocyte count increased.', 'unitOfMeasure': '10^6 cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Absolute Change From Baseline in Hgb ≥ 0.4, 0.6, 0.8, and 1.0 g/dL at the End of Dosing Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Change from Baseline in Hgb ≥0.4 g/dL', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline in Hgb ≥0.6 g/dL', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline in Hgb ≥0.8 g/dL', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline in Hgb ≥1.0 g/dL', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 6 (End of the Dosing Period)', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change From Baseline in Hgb ≥5.0, 7.5, and 10.0% by the End of Dosing Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': '% Change from Baseline in Hgb ≥5%', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': '% Change from Baseline in Hgb ≥7.5%', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '% Change from Baseline in Hgb ≥10.0%', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 6 (End of The Dosing Period)', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change From Baseline in HCT ≥5.0, 7.5, and 10.0% by the End of Dosing Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': '% Change from Baseline in HCT ≥5%', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '% Change from Baseline in HCT ≥7.5%', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '% Change from Baseline in HCT ≥10.0%', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 6 (End of The Dosing Period)', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline HCT was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change From Baseline in RBC Count ≥5.0, 7.5, and 10.0% by the End of Dosing Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': '% Change from Baseline in RBCs ≥5%', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '% Change from Baseline in RBCs ≥7.5%', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': '% Change from Baseline in RBCs ≥10.0%', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 6 (End of The Dosing Period)', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline RBC Count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change From Baseline in Reticulocyte Count ≥6000, 12000, and 18000 Cells/uL by the End of Dosing Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Change from Baseline in Reticulocytes ≥6000 cells/uL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline in Reticulocytes ≥12000 cells/uL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline in Reticulocytes ≥18000 cells/uL', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 6 (End of The Dosing Period)', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline reticulocytes count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Iron at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '66.0', 'spread': '18.68', 'groupId': 'OG000'}, {'value': '77.8', 'spread': '22.47', 'groupId': 'OG001'}, {'value': '76.1', 'spread': '32.01', 'groupId': 'OG002'}, {'value': '60.7', 'spread': '20.51', 'groupId': 'OG003'}, {'value': '67.6', 'spread': '21.12', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '15.87', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '18.96', 'groupId': 'OG001'}, {'value': '10.9', 'spread': '22.93', 'groupId': 'OG002'}, {'value': '10.4', 'spread': '24.54', 'groupId': 'OG003'}, {'value': '-4.1', 'spread': '18.55', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '21.62', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '16.36', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '20.49', 'groupId': 'OG002'}, {'value': '13.2', 'spread': '24.18', 'groupId': 'OG003'}, {'value': '-2.2', 'spread': '20.47', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '23.26', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '15.44', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '25.19', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '16.54', 'groupId': 'OG003'}, {'value': '-8.6', 'spread': '25.81', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-7.4', 'spread': '19.25', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '22.90', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '31.90', 'groupId': 'OG002'}, {'value': '6.2', 'spread': '18.50', 'groupId': 'OG003'}, {'value': '3.4', 'spread': '16.05', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '=0.6051', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.5197', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.1073', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.1321', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.4358', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.8109', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.2575', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.8361', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0294', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.8809', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.4971', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.3994', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.5022', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.9916', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.2292', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.1331', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.5518', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.9032', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.2387', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.4251', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline total iron was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.', 'unitOfMeasure': 'Micrograms per deciliter (µg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Unsaturated Iron Binding Capacity at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '153.4', 'spread': '34.26', 'groupId': 'OG000'}, {'value': '168.0', 'spread': '52.46', 'groupId': 'OG001'}, {'value': '173.1', 'spread': '56.48', 'groupId': 'OG002'}, {'value': '171.2', 'spread': '38.77', 'groupId': 'OG003'}, {'value': '175.5', 'spread': '33.14', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '18.78', 'groupId': 'OG000'}, {'value': '22.4', 'spread': '19.52', 'groupId': 'OG001'}, {'value': '17.2', 'spread': '32.16', 'groupId': 'OG002'}, {'value': '21.3', 'spread': '27.40', 'groupId': 'OG003'}, {'value': '-1.5', 'spread': '20.61', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14.4', 'spread': '25.96', 'groupId': 'OG000'}, {'value': '26.1', 'spread': '22.30', 'groupId': 'OG001'}, {'value': '31.5', 'spread': '27.08', 'groupId': 'OG002'}, {'value': '37.4', 'spread': '20.16', 'groupId': 'OG003'}, {'value': '-3.7', 'spread': '27.89', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15.3', 'spread': '30.52', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '25.62', 'groupId': 'OG001'}, {'value': '29.3', 'spread': '16.06', 'groupId': 'OG002'}, {'value': '49.6', 'spread': '26.50', 'groupId': 'OG003'}, {'value': '-1.3', 'spread': '17.81', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15.1', 'spread': '30.46', 'groupId': 'OG000'}, {'value': '16.2', 'spread': '22.74', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '23.06', 'groupId': 'OG002'}, {'value': '3.9', 'spread': '42.20', 'groupId': 'OG003'}, {'value': '0.7', 'spread': '20.72', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '=0.0448', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0004', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0813', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0038', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.6861', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0553', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0004', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.7379', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0720', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0002', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.6781', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0524', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0367', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.6671', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.6861', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.9012', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Unsaturated Iron Binding Capacity was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.', 'unitOfMeasure': 'µg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Iron Saturation at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '30.4', 'spread': '7.56', 'groupId': 'OG000'}, {'value': '32.4', 'spread': '9.82', 'groupId': 'OG001'}, {'value': '31.4', 'spread': '13.35', 'groupId': 'OG002'}, {'value': '26.5', 'spread': '10.17', 'groupId': 'OG003'}, {'value': '27.7', 'spread': '6.60', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '6.26', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '7.34', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '9.15', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '8.81', 'groupId': 'OG003'}, {'value': '-0.9', 'spread': '7.86', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '8.10', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '7.00', 'groupId': 'OG001'}, {'value': '-3.7', 'spread': '7.91', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '6.52', 'groupId': 'OG003'}, {'value': '-0.2', 'spread': '8.65', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '9.24', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '6.36', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '7.69', 'groupId': 'OG002'}, {'value': '-4.6', 'spread': '6.44', 'groupId': 'OG003'}, {'value': '-2.1', 'spread': '9.09', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '7.08', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '8.90', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '9.94', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '9.27', 'groupId': 'OG003'}, {'value': '1.2', 'spread': '5.80', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '=0.3953', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0850', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.6045', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.7743', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.5326', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.3465', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.2756', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.1414', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.6941', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.9403', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.8310', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0654', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.4169', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0103', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.3968', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0325', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.2151', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.8436', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.5962', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.3957', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline iron saturation was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.', 'unitOfMeasure': 'Percentage of saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '219.4', 'spread': '39.39', 'groupId': 'OG000'}, {'value': '245.8', 'spread': '54.61', 'groupId': 'OG001'}, {'value': '249.2', 'spread': '45.29', 'groupId': 'OG002'}, {'value': '231.8', 'spread': '36.19', 'groupId': 'OG003'}, {'value': '243.1', 'spread': '40.02', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '16.34', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '18.09', 'groupId': 'OG001'}, {'value': '28.1', 'spread': '22.32', 'groupId': 'OG002'}, {'value': '31.7', 'spread': '28.73', 'groupId': 'OG003'}, {'value': '-5.5', 'spread': '22.51', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.9', 'spread': '24.97', 'groupId': 'OG000'}, {'value': '30.1', 'spread': '16.20', 'groupId': 'OG001'}, {'value': '29.9', 'spread': '24.08', 'groupId': 'OG002'}, {'value': '50.5', 'spread': '28.64', 'groupId': 'OG003'}, {'value': '-5.9', 'spread': '17.96', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '18.8', 'spread': '28.81', 'groupId': 'OG000'}, {'value': '36.8', 'spread': '27.76', 'groupId': 'OG001'}, {'value': '33.0', 'spread': '28.54', 'groupId': 'OG002'}, {'value': '50.3', 'spread': '27.80', 'groupId': 'OG003'}, {'value': '-9.9', 'spread': '25.70', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '34.88', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '18.15', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '25.82', 'groupId': 'OG002'}, {'value': '10.2', 'spread': '30.15', 'groupId': 'OG003'}, {'value': '4.1', 'spread': '23.83', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '=0.0294', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0021', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0004', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0925', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0433', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0005', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.1626', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0366', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0004', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0012', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.1779', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.5867', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.1306', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.9889', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.2026', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.5703', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline TIBC was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.', 'unitOfMeasure': 'µg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ferritin at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '349.5', 'spread': '226.27', 'groupId': 'OG000'}, {'value': '245.8', 'spread': '215.18', 'groupId': 'OG001'}, {'value': '332.3', 'spread': '330.81', 'groupId': 'OG002'}, {'value': '240.2', 'spread': '142.10', 'groupId': 'OG003'}, {'value': '200.8', 'spread': '115.99', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-66.0', 'spread': '67.72', 'groupId': 'OG000'}, {'value': '-41.7', 'spread': '53.18', 'groupId': 'OG001'}, {'value': '-72.0', 'spread': '75.89', 'groupId': 'OG002'}, {'value': '-58.9', 'spread': '54.72', 'groupId': 'OG003'}, {'value': '-12.9', 'spread': '35.49', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-69.8', 'spread': '101.67', 'groupId': 'OG000'}, {'value': '-48.7', 'spread': '63.08', 'groupId': 'OG001'}, {'value': '-89.6', 'spread': '138.80', 'groupId': 'OG002'}, {'value': '-80.6', 'spread': '64.50', 'groupId': 'OG003'}, {'value': '-20.5', 'spread': '39.24', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-65.5', 'spread': '115.89', 'groupId': 'OG000'}, {'value': '-59.4', 'spread': '58.76', 'groupId': 'OG001'}, {'value': '-88.9', 'spread': '64.66', 'groupId': 'OG002'}, {'value': '-86.6', 'spread': '62.73', 'groupId': 'OG003'}, {'value': '-19.6', 'spread': '41.72', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-50.4', 'spread': '91.22', 'groupId': 'OG000'}, {'value': '-37.7', 'spread': '73.31', 'groupId': 'OG001'}, {'value': '-86.1', 'spread': '67.75', 'groupId': 'OG002'}, {'value': '-27.4', 'spread': '107.42', 'groupId': 'OG003'}, {'value': '-20.2', 'spread': '39.35', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0092', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0012', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.1157', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 2).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0069', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0034', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0067', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0401', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 4).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0042', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0002', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0422', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Week 6).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0232', 'groupIds': ['OG000'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0243', 'groupIds': ['OG001'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0001', 'groupIds': ['OG002'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.1089', 'groupIds': ['OG003'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0833', 'groupIds': ['OG004'], 'groupDescription': 'p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).', 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Follow-up (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline ferritin was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.', 'unitOfMeasure': 'Nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythropoietin at Week 2, Week 6, and Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '18.011', 'spread': '56.3608', 'groupId': 'OG000'}, {'value': '4.339', 'spread': '4.1462', 'groupId': 'OG001'}, {'value': '7.287', 'spread': '8.8333', 'groupId': 'OG002'}, {'value': '8.826', 'spread': '10.2773', 'groupId': 'OG003'}, {'value': '6.963', 'spread': '14.1425', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-3.538', 'spread': '20.3172', 'groupId': 'OG000'}, {'value': '0.606', 'spread': '3.2070', 'groupId': 'OG001'}, {'value': '1.142', 'spread': '11.8961', 'groupId': 'OG002'}, {'value': '-2.483', 'spread': '9.5483', 'groupId': 'OG003'}, {'value': '-0.850', 'spread': '9.3370', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-3.050', 'spread': '15.1756', 'groupId': 'OG000'}, {'value': '-1.013', 'spread': '3.9836', 'groupId': 'OG001'}, {'value': '-3.329', 'spread': '5.9821', 'groupId': 'OG002'}, {'value': '-0.372', 'spread': '14.4615', 'groupId': 'OG003'}, {'value': '-1.492', 'spread': '10.1597', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline to Follow-up Visit (up to Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-3.853', 'spread': '15.1335', 'groupId': 'OG000'}, {'value': '-0.563', 'spread': '5.5372', 'groupId': 'OG001'}, {'value': '-2.061', 'spread': '6.2689', 'groupId': 'OG002'}, {'value': '-4.844', 'spread': '9.4601', 'groupId': 'OG003'}, {'value': '-2.650', 'spread': '8.2146', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline erythropoietin was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized participants who received at least one dose of study medication. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hepcidin at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '326.35', 'spread': '222.037', 'groupId': 'OG000'}, {'value': '241.03', 'spread': '158.871', 'groupId': 'OG001'}, {'value': '242.51', 'spread': '117.326', 'groupId': 'OG002'}, {'value': '282.75', 'spread': '239.266', 'groupId': 'OG003'}, {'value': '258.29', 'spread': '144.115', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline at Week 6', 'categories': [{'measurements': [{'value': '-28.64', 'spread': '185.263', 'groupId': 'OG000'}, {'value': '-90.91', 'spread': '106.826', 'groupId': 'OG001'}, {'value': '-85.01', 'spread': '45.864', 'groupId': 'OG002'}, {'value': '-144.90', 'spread': '184.640', 'groupId': 'OG003'}, {'value': '-32.54', 'spread': '103.937', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '=0.5456', 'groupIds': ['OG000'], 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0053', 'groupIds': ['OG001'], 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.0040', 'groupIds': ['OG003'], 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}, {'pValue': '=0.2017', 'groupIds': ['OG004'], 'statisticalMethod': '2 sided t-test/Wilcoxon Signed-rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'Change from Baseline was calculated as the Week 6 value minus the Baseline value. Baseline hepcidin was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Plasma Vadadustat Concentrations on Week 2 and Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}], 'classes': [{'title': 'Week 2 Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4358.28', 'spread': '2549.623', 'groupId': 'OG000'}, {'value': '6640.04', 'spread': '5141.484', 'groupId': 'OG001'}, {'value': '10791.79', 'spread': '9823.143', 'groupId': 'OG002'}, {'value': '12443.17', 'spread': '17095.495', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17036.82', 'spread': '8035.308', 'groupId': 'OG000'}, {'value': '21371.63', 'spread': '8664.304', 'groupId': 'OG001'}, {'value': '39892.00', 'spread': '19891.284', 'groupId': 'OG002'}, {'value': '41656.11', 'spread': '20002.713', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4698.21', 'spread': '3520.520', 'groupId': 'OG000'}, {'value': '7884.56', 'spread': '5517.132', 'groupId': 'OG001'}, {'value': '14274.80', 'spread': '16141.439', 'groupId': 'OG002'}, {'value': '17700.17', 'spread': '19532.648', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2: Pre-dose and post-dose; Week 4: Pre-dose', 'description': 'Plasma samples were collected for the analysis.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Population: All participants in the ITT population that had pre-dose PK sampling that fell within a range of 18 to 30 hours after the previous dose of study medication or post-dose PK sampling that fell in a range of 2 to 8 hours post-dose. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Plasma Vadadustat Acyl-Glucuronide Concentrations on Week 2 and Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}], 'classes': [{'title': 'Week 2 Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1848.4', 'spread': '979.73', 'groupId': 'OG000'}, {'value': '2708.5', 'spread': '1879.02', 'groupId': 'OG001'}, {'value': '5900.1', 'spread': '8309.24', 'groupId': 'OG002'}, {'value': '6425.0', 'spread': '7214.67', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1999.3', 'spread': '1427.74', 'groupId': 'OG000'}, {'value': '2687.5', 'spread': '2027.63', 'groupId': 'OG001'}, {'value': '6866.9', 'spread': '9247.39', 'groupId': 'OG002'}, {'value': '7960.8', 'spread': '6643.98', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2: Pre-dose; Week 4: Pre-dose', 'description': 'Plasma samples were collected for the analysis.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 8 (Follow-up Visit 2 weeks after last dose)', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. A TEAE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. A SAE included AEs that met one or more of the following criteria/outcomes: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, and congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Parameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 8 (Follow-up Visit 2 weeks after last dose)', 'description': 'Parameters assessed for vital signs included sitting blood pressure, pulse, respiratory rate, and body temperature. The investigator was responsible for reviewing laboratory results for clinically significant changes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormal 12-Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 8 (Follow-up Visit 2 weeks after last dose)', 'description': 'A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. Clinical significance is determined by the investigator. The investigator was responsible for reviewing laboratory results for clinical significance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'title': 'Baseline PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '156.7', 'spread': '46.90', 'groupId': 'OG000'}, {'value': '174.6', 'spread': '40.89', 'groupId': 'OG001'}, {'value': '172.8', 'spread': '51.06', 'groupId': 'OG002'}, {'value': '187.8', 'spread': '45.72', 'groupId': 'OG003'}, {'value': '175.8', 'spread': '31.82', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '22.95', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '12.37', 'groupId': 'OG001'}, {'value': '11.4', 'spread': '29.72', 'groupId': 'OG002'}, {'value': '-11.7', 'spread': '63.75', 'groupId': 'OG003'}, {'value': '-0.4', 'spread': '13.07', 'groupId': 'OG004'}]}]}, {'title': 'Baseline QRS Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '94.9', 'spread': '21.35', 'groupId': 'OG000'}, {'value': '113.8', 'spread': '37.57', 'groupId': 'OG001'}, {'value': '97.1', 'spread': '28.07', 'groupId': 'OG002'}, {'value': '94.5', 'spread': '12.65', 'groupId': 'OG003'}, {'value': '94.6', 'spread': '12.52', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline QRS Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '9.52', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '13.29', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '7.23', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '10.28', 'groupId': 'OG003'}, {'value': '-1.6', 'spread': '5.33', 'groupId': 'OG004'}]}]}, {'title': 'Baseline QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '412.0', 'spread': '41.59', 'groupId': 'OG000'}, {'value': '421.4', 'spread': '46.58', 'groupId': 'OG001'}, {'value': '419.0', 'spread': '44.97', 'groupId': 'OG002'}, {'value': '406.9', 'spread': '42.97', 'groupId': 'OG003'}, {'value': '419.1', 'spread': '40.10', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '24.78', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '25.33', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '19.83', 'groupId': 'OG002'}, {'value': '4.5', 'spread': '24.10', 'groupId': 'OG003'}, {'value': '11.0', 'spread': '23.35', 'groupId': 'OG004'}]}]}, {'title': 'Baseline QTC Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '424.9', 'spread': '27.70', 'groupId': 'OG000'}, {'value': '436.3', 'spread': '37.56', 'groupId': 'OG001'}, {'value': '445.1', 'spread': '36.10', 'groupId': 'OG002'}, {'value': '427.6', 'spread': '23.60', 'groupId': 'OG003'}, {'value': '435.6', 'spread': '17.90', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline QTC Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '14.33', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '17.65', 'groupId': 'OG001'}, {'value': '-5.8', 'spread': '20.70', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '16.74', 'groupId': 'OG003'}, {'value': '3.3', 'spread': '21.46', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected).', 'unitOfMeasure': 'Milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'OG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'OG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'OG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 8 (Follow-up Visit 2 weeks after last dose)', 'description': 'Parameters assessed for laboratory values included hematology, serum chemistry, C-reactive protein, DHEA-S, VEGF, and cystatin C. The investigator was responsible for reviewing laboratory results for clinically significant changes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'FG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'FG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'FG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal of informed consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Participant given Aranesp injection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 93 participants were enrolled and randomized into the study. Only 91 participants received the treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '91', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'AKB-6548 240 mg', 'description': 'Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.'}, {'id': 'BG001', 'title': 'AKB-6548 370 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.'}, {'id': 'BG002', 'title': 'AKB-6548 500 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 500 mg capsule QD for 42 days.'}, {'id': 'BG003', 'title': 'AKB-6548 630 mg', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of matching Placebo QD for 42 days.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'spread': '12.17', 'groupId': 'BG000'}, {'value': '68.9', 'spread': '7.84', 'groupId': 'BG001'}, {'value': '64.7', 'spread': '9.47', 'groupId': 'BG002'}, {'value': '64.9', 'spread': '8.79', 'groupId': 'BG003'}, {'value': '64.9', 'spread': '9.97', 'groupId': 'BG004'}, {'value': '65.5', 'spread': '9.69', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CKD stage', 'classes': [{'categories': [{'title': 'Stage 3', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}]}, {'title': 'Stage 4', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) Population: All randomized participants who received at least one dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'dispFirstSubmitDate': '2012-10-03', 'completionDateStruct': {'date': '2012-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-07', 'studyFirstSubmitDate': '2011-06-23', 'dispFirstSubmitQcDate': '2012-10-03', 'resultsFirstSubmitDate': '2022-04-22', 'studyFirstSubmitQcDate': '2011-06-23', 'dispFirstPostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-07', 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6)', 'timeFrame': 'Baseline, Week 6', 'description': 'Absolute change from Baseline was calculated as the Week 6 (end of treatment) value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing. If there was only one measurement prior to dosing, this measurement served as Baseline. A positive change from Baseline indicated that hemoglobin concentration increased.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'timeFrame': 'Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that hemoglobin concentration increased.'}, {'measure': 'Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'timeFrame': 'Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline HCT was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated HCT concentration increased.'}, {'measure': 'Change From Baseline in Red Blood Cell (RBC) Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'timeFrame': 'Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline RBC count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated RBC count increased.'}, {'measure': 'Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'timeFrame': 'Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Reticulocyte count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated reticulocyte count increased.'}, {'measure': 'Change From Baseline in Reticulocyte Hgb Content at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'Change from Baseline was calculated as the Week 6 value minus the Baseline value. Baseline Reticulocyte count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated reticulocyte Hgb content increased.'}, {'measure': 'Maximum Change From Baseline in Hgb', 'timeFrame': 'Baseline; up to Week 8', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that hemoglobin concentration increased.'}, {'measure': 'Maximum Change From Baseline in HCT', 'timeFrame': 'Baseline; up to Week 8', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline HCT was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that HCT concentration increased.'}, {'measure': 'Maximum Change From Baseline in RBC Count', 'timeFrame': 'Baseline; up to Week 8', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline RBC Count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that RBC count increased.'}, {'measure': 'Maximum Change in Absolute Reticulocyte Count From Baseline', 'timeFrame': 'Baseline; up to Week 8', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline absolute reticulocyte count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that reticulocyte count increased.'}, {'measure': 'Number of Participants With Absolute Change From Baseline in Hgb ≥ 0.4, 0.6, 0.8, and 1.0 g/dL at the End of Dosing Period', 'timeFrame': 'Up to Week 6 (End of the Dosing Period)', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.'}, {'measure': 'Number of Participants With Change From Baseline in Hgb ≥5.0, 7.5, and 10.0% by the End of Dosing Period', 'timeFrame': 'Up to Week 6 (End of The Dosing Period)', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.'}, {'measure': 'Number of Participants With Change From Baseline in HCT ≥5.0, 7.5, and 10.0% by the End of Dosing Period', 'timeFrame': 'Up to Week 6 (End of The Dosing Period)', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline HCT was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.'}, {'measure': 'Number of Participants With Change From Baseline in RBC Count ≥5.0, 7.5, and 10.0% by the End of Dosing Period', 'timeFrame': 'Up to Week 6 (End of The Dosing Period)', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline RBC Count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.'}, {'measure': 'Number of Participants With Change From Baseline in Reticulocyte Count ≥6000, 12000, and 18000 Cells/uL by the End of Dosing Period', 'timeFrame': 'Up to Week 6 (End of The Dosing Period)', 'description': 'Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline reticulocytes count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.'}, {'measure': 'Change From Baseline in Total Iron at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline total iron was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.'}, {'measure': 'Change From Baseline in Unsaturated Iron Binding Capacity at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Unsaturated Iron Binding Capacity was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.'}, {'measure': 'Change From Baseline in Iron Saturation at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline iron saturation was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.'}, {'measure': 'Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline TIBC was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.'}, {'measure': 'Change From Baseline in Ferritin at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Follow-up (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline ferritin was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.'}, {'measure': 'Change From Baseline in Erythropoietin at Week 2, Week 6, and Follow-up Visit (up to Week 8)', 'timeFrame': 'Baseline, Week 2, Week 6, Follow-up Visit (up to Week 8)', 'description': 'Change from Baseline was calculated as the visit value minus the Baseline value. Baseline erythropoietin was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.'}, {'measure': 'Change From Baseline in Hepcidin at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'Change from Baseline was calculated as the Week 6 value minus the Baseline value. Baseline hepcidin was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline.'}, {'measure': 'Mean Plasma Vadadustat Concentrations on Week 2 and Week 4', 'timeFrame': 'Week 2: Pre-dose and post-dose; Week 4: Pre-dose', 'description': 'Plasma samples were collected for the analysis.'}, {'measure': 'Mean Plasma Vadadustat Acyl-Glucuronide Concentrations on Week 2 and Week 4', 'timeFrame': 'Week 2: Pre-dose; Week 4: Pre-dose', 'description': 'Plasma samples were collected for the analysis.'}, {'measure': 'Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Week 8 (Follow-up Visit 2 weeks after last dose)', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. A TEAE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. A SAE included AEs that met one or more of the following criteria/outcomes: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, and congenital anomaly/birth defect.'}, {'measure': 'Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Parameter', 'timeFrame': 'Up to Week 8 (Follow-up Visit 2 weeks after last dose)', 'description': 'Parameters assessed for vital signs included sitting blood pressure, pulse, respiratory rate, and body temperature. The investigator was responsible for reviewing laboratory results for clinically significant changes.'}, {'measure': 'Number of Participants With Clinically Significant Abnormal 12-Electrocardiogram (ECG) Findings', 'timeFrame': 'Up to Week 8 (Follow-up Visit 2 weeks after last dose)', 'description': 'A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. Clinical significance is determined by the investigator. The investigator was responsible for reviewing laboratory results for clinical significance.'}, {'measure': 'Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval', 'timeFrame': 'Baseline, Week 6', 'description': 'A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected).'}, {'measure': 'Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values', 'timeFrame': 'Up to Week 8 (Follow-up Visit 2 weeks after last dose)', 'description': 'Parameters assessed for laboratory values included hematology, serum chemistry, C-reactive protein, DHEA-S, VEGF, and cystatin C. The investigator was responsible for reviewing laboratory results for clinically significant changes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anemia', 'chronic kidney disease', 'CKD', 'chronic renal insufficiency', 'renal impairment', 'erythropoietin', 'safety', 'efficacy', 'tolerability', 'pharmacokinetics'], 'conditions': ['Anemia', 'Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '36005278', 'type': 'DERIVED', 'citation': 'Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.'}, {'pmid': '28343225', 'type': 'DERIVED', 'citation': 'Martin ER, Smith MT, Maroni BJ, Zuraw QC, deGoma EM. Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease. Am J Nephrol. 2017;45(5):380-388. doi: 10.1159/000464476. Epub 2017 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat dosing for 42 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* 18 to 79 years of age, inclusive\n* Chronic Kidney Disease (eGFR \\<60 mL/min), not yet on dialysis\n* Hemoglobin (Hgb) ≤ 10.5 g/dL\n* Transferring saturation ≥ 20%\n* Ferritin ≥ 50 ng/mL\n\nKey Exclusion Criteria:\n\n* Body mass index \\>42\n* Red blood cell transfusion within 12 weeks\n* Androgen therapy within the previous 21 days prior to study dosing\n* Therapy with any approved or experimental erythropoiesis stimulating agent (ESA) within the 11 weeks prior to the Screening visit\n* Participants meeting the criteria of ESA resistance within the previous 4 months\n* Individual doses of intravenous iron of greater than 250 mg within the past 21 days\n* Aspartate aminotransferase or alanine aminotransferase \\>1.8x upper limit of normal (ULN)\n* Alkaline phosphatase \\>2x ULN\n* Total bilirubin \\>1.5x ULN\n* Uncontrolled hypertension\n* New York Heart Association Class III or IV congestive heart failure\n* Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing'}, 'identificationModule': {'nctId': 'NCT01381094', 'briefTitle': '42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akebia Therapeutics'}, 'officialTitle': 'Phase 2a Randomized, Double-Blind, Placebo-Controlled, Dose Range Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 42-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and 4', 'orgStudyIdInfo': {'id': 'AKB-6548-CI-0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AKB-6548 240 mg', 'interventionNames': ['Drug: AKB-6548']}, {'type': 'EXPERIMENTAL', 'label': 'AKB-6548 370 mg', 'interventionNames': ['Drug: AKB-6548']}, {'type': 'EXPERIMENTAL', 'label': 'AKB-6548 500 mg', 'interventionNames': ['Drug: AKB-6548']}, {'type': 'EXPERIMENTAL', 'label': 'AKB-6548 630 mg', 'interventionNames': ['Drug: AKB-6548']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AKB-6548', 'type': 'DRUG', 'description': 'oral dose administered once daily for 42 days', 'armGroupLabels': ['AKB-6548 240 mg', 'AKB-6548 370 mg', 'AKB-6548 500 mg', 'AKB-6548 630 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral Placebo administered once daily for 42 days', 'armGroupLabels': ['Placebo']}]}, 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