Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-01-01 @ 11:57 PM
Study NCT ID:
NCT04707768
Status:
COMPLETED
Last Update Posted:
2025-01-15
First Post:
2021-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney 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'}, {'id': 'C508420', 'term': 'continuous erythropoietin receptor activator'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trials@akebia.com', 'phone': '6178446128', 'title': 'Akebia Therapeutics, Inc.', 'organization': 'Akebia Therapeutics, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 through Week 56', 'description': 'Safety Population included all participants who received at least 1 dose of study medication', 'eventGroups': [{'id': 'EG000', 'title': 'Vadadustat 600 mg TIW', 'description': 'Participants were randomized to receive Vadadustat at an initial oral dose of 600 mg TIW. Up-and-down titration was allowed during the study based on Hb level measurements to maintain target Hb level', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 61, 'seriousNumAtRisk': 151, 'deathsNumAffected': 14, 'seriousNumAffected': 68}, {'id': 'EG001', 'title': 'Vadadustat 900 mg TIW', 'description': 'Participants were randomized to receive Vadadustat at an initial oral dose of 900 mg TIW. Up-and-down titration was allowed during the study based on Hb level measurements to maintain target Hb level', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 67, 'seriousNumAtRisk': 150, 'deathsNumAffected': 12, 'seriousNumAffected': 66}, {'id': 'EG002', 'title': 'Mircera®', 'description': 'Participants were randomized to Mircera® were already on Mircera®, the initial dosing regimen in the study was based on the prior dosing regimen', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 64, 'seriousNumAtRisk': 150, 'deathsNumAffected': 17, 'seriousNumAffected': 67}], 'otherEvents': [{'term': 'COVID 19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Arteriovenous fistula site complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'COVID 19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'COVID 19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Arteriovenous fistula site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Arteriovenous graft site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cellulitis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Appendiceal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Asymptomatic COVID 19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cellulitis gangrenous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Chest wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Enterococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Enterococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gastroenteritis Escherichia coli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Herpes zoster meningoencephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pancreatic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Parainfluenzae virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pseudomonal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Streptococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Varicella zoster virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vascular access site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Viral sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 4}, {'groupId': 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25.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Benign uterine neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Renal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hyperparathyroidism secondary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Blindness transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Thrombosis in device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Social stay hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vadadustat 600 mg TIW', 'description': 'Participants were randomized to receive Vadadustat at an initial oral dose of 600 mg TIW. Up-and-down titration was allowed during the study based on Hb level measurements to maintain target Hb level'}, {'id': 'OG001', 'title': 'Vadadustat 900 mg TIW', 'description': 'Participants were randomized to receive Vadadustat at an initial oral dose of 900 mg TIW. Up-and-down titration was allowed during the study based on Hb level measurements to maintain target Hb level'}, {'id': 'OG002', 'title': 'Mircera®', 'description': 'Participants were randomized to Mircera® were already on Mircera®, the initial dosing regimen in the study was based on the prior dosing regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.095', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '0.092', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Weeks 20 to 26', 'description': 'The Baseline Hb was defined as the average of last 2 central laboratory Hb measurements of samples taken at or prior to the first dose. The average for the PEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 20 through 26. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as PEP value minus the Baseline value.', 'unitOfMeasure': 'Grams per deciliter (g/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vadadustat 600 mg TIW', 'description': 'Participants were randomized to receive Vadadustat at an initial oral dose of 600 mg TIW. Up-and-down titration was allowed during the study based on Hb level measurements to maintain target Hb level'}, {'id': 'OG001', 'title': 'Vadadustat 900 mg TIW', 'description': 'Participants were randomized to receive Vadadustat at an initial oral dose of 900 mg TIW. Up-and-down titration was allowed during the study based on Hb level measurements to maintain target Hb level'}, {'id': 'OG002', 'title': 'Mircera®', 'description': 'Participants were randomized to Mircera® were already on Mircera®, the initial dosing regimen in the study was based on the prior dosing regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.110', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.123', 'groupId': 'OG001'}, {'value': '0.16', 'spread': '0.102', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Weeks 46 to 52', 'description': 'The Baseline Hb was defined as the average of the last 2 central laboratory Hb values taken on or prior to the first dose date. The average for the SEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 46 through 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as SEP value minus the Baseline value.', 'unitOfMeasure': 'Grams per deciliter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vadadustat 600 mg TIW', 'description': 'Participants were randomized to receive Vadadustat at an initial oral dose of 600 mg TIW. Up-and-down titration was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb level'}, {'id': 'FG001', 'title': 'Vadadustat 900 mg TIW', 'description': 'Participants were randomized to receive Vadadustat at an initial oral dose of 900 mg TIW. Up-and-down titration was allowed during the study based on Hb level measurements to maintain target Hb level'}, {'id': 'FG002', 'title': 'Mircera®', 'description': 'Participants were randomized to Mircera® were already on Mircera®, the initial dosing regimen in the study was based on the prior dosing regimen'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '152'}, {'groupId': 'FG002', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This was a randomzied, open-label, active-controlled study of the efficacy and safety of conversion from long-acting Erythropoiesis-stimulating Agent (ESA) (Methoxy polyethylene glycol-epoetin beta \\[Mircera®\\]) to vadadustat Three Times Weekly (TIW) for the maintenance treatment of anemia in hemodialysis participants.', 'preAssignmentDetails': "A total of 456 participants were enrolled in the study. Participants were randomized 1:1:1 to Vadadustat 600 milligrams (mg) TIW Vadadustat 900 mg TIW or to remain on Mircera® according to the dialysis center's protocol."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '456', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Vadadustat 600 mg TIW', 'description': 'Participants were randomized to receive Vadadustat at an initial oral dose of 600 mg TIW. Up-and-down titration was allowed during the study based on Hb level measurements to maintain target Hb level'}, {'id': 'BG001', 'title': 'Vadadustat 900 mg TIW', 'description': 'Participants were randomized to receive Vadadustat at an initial oral dose of 900 mg TIW. Up-and-down titration was allowed during the study based on Hb level measurements to maintain target Hb level'}, {'id': 'BG002', 'title': 'Mircera®', 'description': 'Participants were randomized to Mircera® were already on Mircera®, the initial dosing regimen in the study was based on the prior dosing regimen'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'spread': '14.20', 'groupId': 'BG000'}, {'value': '61.9', 'spread': '13.27', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '12.80', 'groupId': 'BG002'}, {'value': '61.0', 'spread': '13.45', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '262', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '314', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '265', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized population included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-16', 'size': 1241309, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-23T08:21', 'hasProtocol': True}, {'date': '2022-10-31', 'size': 796230, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-23T08:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 456}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'dispFirstSubmitDate': '2023-12-14', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2021-01-12', 'resultsFirstSubmitDate': '2024-12-23', 'studyFirstSubmitQcDate': '2021-01-12', 'dispFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-23', 'studyFirstPostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)', 'timeFrame': 'Baseline; Weeks 20 to 26', 'description': 'The Baseline Hb was defined as the average of last 2 central laboratory Hb measurements of samples taken at or prior to the first dose. The average for the PEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 20 through 26. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as PEP value minus the Baseline value.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52)', 'timeFrame': 'Baseline; Weeks 46 to 52', 'description': 'The Baseline Hb was defined as the average of the last 2 central laboratory Hb values taken on or prior to the first dose date. The average for the SEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 46 through 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as SEP value minus the Baseline value.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anemia', 'Chronic Kidney Disease', 'CKD', 'Hemodialysis', 'Vadadustat', 'Erythropoiesis-stimulating agent (ESA)'], 'conditions': ['Anemia Associated With Chronic Kidney Disease (CKD)']}, 'referencesModule': {'references': [{'pmid': '39521398', 'type': 'DERIVED', 'citation': 'Toka HR, Bernardo M, Burke SK, Luo W, Manllo-Karim R, Ullah I, Yang Z, Zhang Z, Tumlin J. Vadadustat Three Times Weekly in Patients With Anemia Due to Dialysis-Dependent CKD. Am J Kidney Dis. 2025 Apr;85(4):454-464.e1. doi: 10.1053/j.ajkd.2024.09.006. Epub 2024 Nov 7.'}, {'pmid': '39231617', 'type': 'DERIVED', 'citation': 'Kooienga L, Burke S, Kathresal A, Luo W, Yang Z, Zhang Z, Zwiech R, Hernandez GT. Safety and Efficacy of Vadadustat Once Daily and Three Times Weekly in Patients With Dialysis-Dependent CKD With Anemia. Kidney360. 2024 Nov 1;5(11):1652-1661. doi: 10.34067/KID.0000000567. Epub 2024 Sep 4.'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants.', 'detailedDescription': 'Following randomization, there will be 2 periods during the study:\n\n* Conversion and Maintenance Period (Weeks 0 to 52): There will be a primary efficacy evaluation period (Weeks 20 to 26) and a secondary efficacy evaluation period (Weeks 46 to 52).\n* Safety Follow-up Period (Early Termination \\[ET\\] and Follow-Up): post-treatment safety follow-up visit (ET/End of Treatment \\[EOT\\] +4 weeks) either in person or via telephone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age\n* Receiving chronic, outpatient in-center hemodialysis three times weekly (TIW) for end-stage kidney disease for at least 12 weeks prior to Screening Visit 1 (SV1)\n* Currently maintained on Mircera® (≤250 μg/month) with at least 2 doses received within 8 weeks prior to Screening Visit 2 (SV2)\n* Mean Screening hemoglobin (Hb) between 8.5 and 11.0 grams per deciliter (g/dL) (inclusive), as determined by the average of 2 Hb values measured by the central laboratory at least 4 days apart between SV1 and SV2\n* Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening\n* Folate and vitamin B12 measurements ≥ lower limit of normal during Screening\n\nExclusion Criteria:\n\n* Anemia due to a cause other than chronic kidney disease (CKD).\n* Clinically meaningful bleeding event within 8 weeks prior to Baseline\n* Red blood cell (RBC) transfusion within 8 weeks prior to Baseline\n* Having received any doses of darbepoetin alfa (Aranesp®) within 4 weeks prior to Baseline\n* Having received any doses of epoetin alfa (Epogen®) within 1 week prior to Baseline.\n* Current uncontrolled hypertension.\n* Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure (HF) or New York Heart Association Class IV HF, or stroke within 12 weeks prior to or during Screening.\n* Known hypersensitivity to vadadustat, Mircera®, or any of their excipients.'}, 'identificationModule': {'nctId': 'NCT04707768', 'briefTitle': 'Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akebia Therapeutics'}, 'officialTitle': 'A Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects', 'orgStudyIdInfo': {'id': 'AKB-6548-CI-0039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vadadustat low dose', 'description': 'Participants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 600 milligrams (mg).', 'interventionNames': ['Drug: Vadadustat']}, {'type': 'EXPERIMENTAL', 'label': 'Vadadustat high dose', 'description': 'Participants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 900 mg.', 'interventionNames': ['Drug: Vadadustat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mircera®', 'description': 'Participants will continue to receive Mircera® for up to 52 weeks.', 'interventionNames': ['Drug: Mircera®']}], 'interventions': [{'name': 'Vadadustat', 'type': 'DRUG', 'description': 'oral tablets', 'armGroupLabels': ['Vadadustat high dose', 'Vadadustat low dose']}, {'name': 'Mircera®', 'type': 'DRUG', 'description': 'intravenous administration', 'armGroupLabels': ['Mircera®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85035', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '71603', 'city': 'Pine Bluff', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.22843, 'lon': -92.0032}}, {'zip': '92243', 'city': 'El Centro', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.792, 'lon': -115.56305}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '91344', 'city': 'Granada Hills', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.26472, 'lon': -118.52314}}, {'zip': '93257', 'city': 'Porterville', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.06523, 'lon': -119.01677}}, {'zip': '92111', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80002', 'city': 'Arvada', 'state': 'Colorado', 'country': 'United States', 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'Research Site', 'geoPoint': {'lat': 38.65817, 'lon': -77.2497}}], 'overallOfficials': [{'name': 'Chief Medical Officer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Akebia Therapeutics Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akebia Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}