Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-26 @ 5:15 PM
Study NCT ID:
NCT00440557
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2007-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D000068817', 'term': 'Epoetin Alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '908-927-2116', 'title': 'Sr Director of Clinical Research', 'organization': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'certainAgreement': {'otherDetails': "Disclosure restrictions on the PI are pre- review of publications prior to public release. Sponsor can embargo trial result publication for up to 120 days. The PI may not publish the sponsor's confidential information without consent. In multi-center trials, individual PI's may publish results only if the study group has not published results 12 months after study completion, abandonment, or termination. The sponsor cannot require changes to the scientific content and cannot extend the embargo.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '44 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)', 'description': 'Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)', 'otherNumAtRisk': 123, 'otherNumAffected': 93, 'seriousNumAtRisk': 123, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'Epoetin Alfa:Once Weekly (QW)', 'description': 'Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)', 'otherNumAtRisk': 125, 'otherNumAffected': 85, 'seriousNumAtRisk': 125, 'seriousNumAffected': 41}, {'id': 'EG002', 'title': 'Epoetin Alfa:Once Every Two Weeks (Q2W)', 'description': 'Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)', 'otherNumAtRisk': 125, 'otherNumAffected': 102, 'seriousNumAtRisk': 125, 'seriousNumAffected': 42}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Subendocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Peritonitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hyperammonaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Prostatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Walking disability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)', 'description': 'Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)'}, {'id': 'OG001', 'title': 'Epoetin Alfa:Once Weekly (QW)', 'description': 'Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)'}, {'id': 'OG002', 'title': 'Epoetin Alfa:Once Every Two Weeks (Q2W)', 'description': 'Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.81', 'spread': '0.910', 'groupId': 'OG000'}, {'value': '1.59', 'spread': '0.997', 'groupId': 'OG001'}, {'value': '1.27', 'spread': '0.906', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of Least Squares Means', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.380', 'ciUpperLimit': '0.037', 'pValueComment': 'This comparison between QW and TIW was performed prior to comparing Q2W with TIW in the statistical analysis 2 according to a planned stepdown procedure for controlling multiplicity.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.106', 'groupDescription': 'The null hypothesis is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment (tX) through Week 22 in the QW group is not lower than that of the TIW group by more than 1 g/dL.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assuming a difference in the mean change in Hb from baseline to the average of the last 8 weeks of treatment through Week 22 of -0.3 g/dL between standard-tx group (TIW) and test-tx group (QW), a pooled standard deviation of 1.7 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 250 participants (125 per group) will provide 90% power to demonstrate that the test treatment group is not inferior to the standard-treatment group for an overall 2-sided 0.05 significance level'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of Least Squares Means', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-0.641', 'ciUpperLimit': '-0.221', 'pValueComment': 'Since the non-inferiority was declared in the statistical analysis 1, this comparison between Q2W and TIW was then performed according to a planned stepdown procedure for controlling multiplicity.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.107', 'groupDescription': 'The null hypothesis is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment through Week 22 in the Q2W group is not lower than that of the TIW group by more than 1 g/dL.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assuming a difference in the mean change in Hb from baseline to the average of the last 8 weeks of treatment through Week 22 of -0.3 g/dL between standard-tx group (TIW) and test-tx group (QW), a pooled standard deviation of 1.7 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 250 participants (125 per group) will provide 90% power to demonstrate that the test treatment group is not inferior to the standard-treatment group for an overall 2-sided 0.05 significance level'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline through Week 22', 'description': 'The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-To-Treat (mITT) population. The mITT population was defined as all participants who were randomized and had at least 1 postrandomization hemoglobin concentration measurement.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)', 'description': 'Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)'}, {'id': 'OG001', 'title': 'Epoetin Alfa:Once Weekly (QW)', 'description': 'Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)'}, {'id': 'OG002', 'title': 'Epoetin Alfa:Once Every Two Weeks (Q2W)', 'description': 'Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciPctValue': '95', 'paramValue': '-7.8', 'ciLowerLimit': '-17.2', 'ciUpperLimit': '1.7', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage of Participants', 'ciPctValue': '95', 'paramValue': '-15.0', 'ciLowerLimit': '-25.0', 'ciUpperLimit': '-5.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to Week 22', 'description': 'The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. participants who exceed a Hb value of 11.9 g/dL at least once were included in the numerator of the percentage calculation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maximum Hb Concentration (g/dL) During First 22 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)', 'description': 'Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)'}, {'id': 'OG001', 'title': 'Epoetin Alfa:Once Weekly (QW)', 'description': 'Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)'}, {'id': 'OG002', 'title': 'Epoetin Alfa:Once Every Two Weeks (Q2W)', 'description': 'Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)'}], 'classes': [{'categories': [{'measurements': [{'value': '12.87', 'spread': '1.176', 'groupId': 'OG000'}, {'value': '12.61', 'spread': '1.158', 'groupId': 'OG001', 'lowerLimit': '-0.564', 'upperLimit': '0.043'}, {'value': '12.42', 'spread': '1.310', 'groupId': 'OG002', 'lowerLimit': '-0.755', 'upperLimit': '-0.147'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of Least Squares Means', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.564', 'ciUpperLimit': '0.043', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of Least Squares Means', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.755', 'ciUpperLimit': '-0.147', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 22', 'description': 'The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. A maximum Hb observation was identified for each participant during the first 22 weeks of treatment.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants Who Met or Exceeded Hb Rate of Rise >=1.0 g/dL/2 Weeks During First 22 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)', 'description': 'Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)'}, {'id': 'OG001', 'title': 'Epoetin Alfa:Once Weekly (QW)', 'description': 'Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)'}, {'id': 'OG002', 'title': 'Epoetin Alfa:Once Every Two Weeks (Q2W)', 'description': 'Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-9.5', 'ciUpperLimit': '1.6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage of Participants', 'ciPctValue': '95', 'paramValue': '-5.5', 'ciLowerLimit': '-11.4', 'ciUpperLimit': '0.3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to Week 22', 'description': 'Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. The safety population was defined as all subjects who received at least 1 injection of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants Who Met or Exceeded Hb Rate of Rise >=1.5 g/dL/2 Weeks During First 22 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)', 'description': 'Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)'}, {'id': 'OG001', 'title': 'Epoetin Alfa:Once Weekly (QW)', 'description': 'Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)'}, {'id': 'OG002', 'title': 'Epoetin Alfa:Once Every Two Weeks (Q2W)', 'description': 'Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-14.2', 'ciUpperLimit': '8.7', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage of Participants', 'ciPctValue': '95', 'paramValue': '-9.9', 'ciLowerLimit': '-21.7', 'ciUpperLimit': '1.8', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to Week 22', 'description': 'Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.5 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Particpants Who Met or Exceeded Hb Rate of Rise >=2.0 g/dL/2 Weeks During First 22 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)', 'description': 'Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)'}, {'id': 'OG001', 'title': 'Epoetin Alfa:Once Weekly (QW)', 'description': 'Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)'}, {'id': 'OG002', 'title': 'Epoetin Alfa:Once Every Two Weeks (Q2W)', 'description': 'Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-9.6', 'ciUpperLimit': '14.8', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage of Participants', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-15.0', 'ciUpperLimit': '9.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to Week 22', 'description': 'Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 2.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.'}, {'type': 'POST_HOC', 'title': 'Maximum (Max) Hb Rate (g/dL/2 Weeks) of Rise During First 22 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)', 'description': 'Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)'}, {'id': 'OG001', 'title': 'Epoetin Alfa:Once Weekly (QW)', 'description': 'Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)'}, {'id': 'OG002', 'title': 'Epoetin Alfa:Once Every Two Weeks (Q2W)', 'description': 'Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.99', 'spread': '0.839', 'groupId': 'OG000'}, {'value': '2.02', 'spread': '1.008', 'groupId': 'OG001', 'lowerLimit': '-0.210', 'upperLimit': '0.270'}, {'value': '1.92', 'spread': '1.027', 'groupId': 'OG002', 'lowerLimit': '-0.315', 'upperLimit': '0.166'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of Least Squares Means', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.210', 'ciUpperLimit': '0.270', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of Least Squares Means', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.315', 'ciUpperLimit': '0.166', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 22', 'description': 'Change is calculated as mean hemoglobin (Hb) over last 8 wks subtracts baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Max Hb RR observation was identified for each participant during the 1st 22 wks of treatment. This was the max RR in hemoglobin over any 2-wk period per participant.', 'unitOfMeasure': 'g/dL/2 weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.'}, {'type': 'SECONDARY', 'title': 'Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)', 'description': 'Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)'}, {'id': 'OG001', 'title': 'Epoetin Alfa:Once Weekly (QW)', 'description': 'Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)'}, {'id': 'OG002', 'title': 'Epoetin Alfa:Once Every Two Weeks (Q2W)', 'description': 'Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciPctValue': '95', 'paramValue': '-8.8', 'ciLowerLimit': '-16', 'ciUpperLimit': '-1.9', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage of Participants', 'ciPctValue': '95', 'paramValue': '-10.0', 'ciLowerLimit': '-18.0', 'ciUpperLimit': '-3.2', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to Week 9', 'description': 'The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Hb increase is defined as the post-baseline Hb level minus the baseline Hb level.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-To-Treat (mITT) population. The mITT population was defined as all participants who were randomized and had at least 1 postrandomization Hb concentration measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)', 'description': 'Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)'}, {'id': 'FG001', 'title': 'Epoetin Alfa:Once Weekly (QW)', 'description': 'Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)'}, {'id': 'FG002', 'title': 'Epoetin Alfa:Once Every Two Weeks (Q2W)', 'description': 'Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Safety population defined as all subjects who received at least 1 injection of study drug.', 'groupId': 'FG000', 'numSubjects': '123'}, {'comment': 'Safety population defined as all subjects who received at least 1 injection of study drug.', 'groupId': 'FG001', 'numSubjects': '125'}, {'comment': 'Safety population defined as all subjects who received at least 1 injection of study drug.', 'groupId': 'FG002', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Began Dialysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Principal Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Patient moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': "Principal Investigator's office closed", 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Patient transferred to nursing home', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Patient had surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was initiated 29 August 2006 and completed on 21 February 2008. Subjects were screened for eligibility at 64 investigative sites within the U.S. Three hundred seventy-five subjects (intent to treat) were randomly assigned to a treatment group by 52 investigators from 56 sites. Safety population consisted of 373 subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '373', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)', 'description': 'Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)'}, {'id': 'BG001', 'title': 'Epoetin Alfa:Once Weekly (QW)', 'description': 'Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)'}, {'id': 'BG002', 'title': 'Epoetin Alfa:Once Every Two Weeks (Q2W)', 'description': 'Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '253', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.1', 'spread': '13.02', 'groupId': 'BG000'}, {'value': '68.9', 'spread': '11.86', 'groupId': 'BG001'}, {'value': '68.9', 'spread': '13.02', 'groupId': 'BG002'}, {'value': '69.6', 'spread': '12.65', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 375}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-22', 'studyFirstSubmitDate': '2007-02-26', 'resultsFirstSubmitDate': '2009-02-23', 'studyFirstSubmitQcDate': '2007-02-26', 'lastUpdatePostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-02', 'studyFirstPostDateStruct': {'date': '2007-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment', 'timeFrame': 'From baseline to Week 22', 'description': 'The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. participants who exceed a Hb value of 11.9 g/dL at least once were included in the numerator of the percentage calculation.'}, {'measure': 'Maximum Hb Concentration (g/dL) During First 22 Weeks of Treatment', 'timeFrame': 'From baseline to Week 22', 'description': 'The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. A maximum Hb observation was identified for each participant during the first 22 weeks of treatment.'}, {'measure': 'Participants Who Met or Exceeded Hb Rate of Rise >=1.0 g/dL/2 Weeks During First 22 Weeks of Treatment', 'timeFrame': 'From baseline to Week 22', 'description': 'Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.'}, {'measure': 'Participants Who Met or Exceeded Hb Rate of Rise >=1.5 g/dL/2 Weeks During First 22 Weeks of Treatment', 'timeFrame': 'From baseline to Week 22', 'description': 'Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.5 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.'}, {'measure': 'Particpants Who Met or Exceeded Hb Rate of Rise >=2.0 g/dL/2 Weeks During First 22 Weeks of Treatment', 'timeFrame': 'From baseline to Week 22', 'description': 'Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 2.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.'}], 'primaryOutcomes': [{'measure': 'Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22', 'timeFrame': 'From baseline through Week 22', 'description': 'The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22.'}], 'secondaryOutcomes': [{'measure': 'Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9', 'timeFrame': 'From baseline to Week 9', 'description': 'The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Hb increase is defined as the post-baseline Hb level minus the baseline Hb level.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anemia', 'Chronic Kidney disease', 'Kidney disease', 'Epoetin alfa', 'Procrit'], 'conditions': ['Anemia']}, 'referencesModule': {'references': [{'pmid': '19808215', 'type': 'DERIVED', 'citation': 'Pergola PE, Gartenberg G, Fu M, Wolfson M, Rao S, Bowers P. A randomized controlled study of weekly and biweekly dosing of epoetin alfa in CKD Patients with anemia. Clin J Am Soc Nephrol. 2009 Nov;4(11):1731-40. doi: 10.2215/CJN.03470509. Epub 2009 Sep 17.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=32&filename=CR010411_CSR.pdf', 'label': 'A Randomized,Open-Label, Multicenter Study of Epoetin Alfa Comparing Two Extended-Dosing Regimens,OnceWeekly and EveryTwoWeeks,With the ThreeTimesWeekly Dosing Regimen for Initiation \\& Maintenance Treatment in Anemic Subjects With Chronic Kidney Disease'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not less effective than the approved treatment with epoetin alfa that is given 3 times weekly with respect to changes in hemoglobin.', 'detailedDescription': 'This is a open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), multicenter study designed to show that 2 alternative dosing regimens, once weekly and once every-2-weeks (given at doses equivalent to 50 IU/kg 3 times a week) are not inferior to the 3-times-weekly dosing regimen. Approximately 375 patients with anemia will be enrolled in this study. Patients will be randomly assigned to receive epoetin alfa by subcutaneous (SC) injection according to one of the following 3 regimens: 3 times weekly (Group 1), once weekly (Group 2), or once every 2 weeks (Group 3) for 22 weeks. Thereafter, patients in Group 1 will be switched to the once-weekly dosing regimen for an additional 22 weeks, and patients in Groups 2 and 3 will continue their current treatment for an additional 22 weeks. The total duration of the open-label treatment phase is 44 weeks which will include initiation and maintenance treatment periods (with the goal of increasing, then maintaining, the hemoglobin level between 11.0 and 11.9 g/dL inclusive) and a safety period (to assess longer exposure to epoetin alfa treatment and any period of hemoglobin instability during the transition from 3-times-weekly to once-weekly dosing). Starting doses of epoetin alfa in the 3-times-weekly, once-weekly, and every-2-weeks groups will be 50 IU/kg, 10,000 IU, and 20,000 IU, respectively; thereafter adjusted according to weekly hemoglobin concentrations. Safety evaluations will include assessment of adverse events, laboratory tests, physical examinations, and vital signs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) more than or equal to 15 mL/min per 1.73 m2 and less than 60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory\n* Require support of an erythropoietin receptor agonist\n\nExclusion Criteria:\n\n* Uncontrolled hypertension\n* Serum ferritin level less than 50 ng/mL\n* Serum iron overload\n* Severe congestive heart failure\n* Active infection'}, 'identificationModule': {'nctId': 'NCT00440557', 'briefTitle': 'An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'officialTitle': 'A Randomized, Open Label, Multicenter Study of Epoetin Alfa Comparing Two Extended-Dosing Regimens, Once-Weekly and Every-Two-Weeks, With the Three-Times-Weekly Dosing Regimen for Initiation and Maintenance Treatment in Anemic Subjects With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'CR010411'}, 'secondaryIdInfos': [{'id': 'EPOAKD3001', 'type': 'OTHER', 'domain': 'Johnson & Johnson Pharmaceutical Research and Development, L.L.C.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TIW: Epoetin alfa 3 injections Weekly/Once Weekly', 'description': 'Participants will be administered with epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)', 'interventionNames': ['Drug: Epoetin alfa 3 times weekly /once weekly']}, {'type': 'EXPERIMENTAL', 'label': 'QW: Epoetin alfa once weekly', 'description': 'Participants will be administered with epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU).', 'interventionNames': ['Drug: Epoetin alfa once weekly']}, {'type': 'EXPERIMENTAL', 'label': 'Q2W: Epoetin alfa once every two weeks', 'description': 'Participants will be administered with epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU).', 'interventionNames': ['Drug: Epoetin alfa once every two weeks']}], 'interventions': [{'name': 'Epoetin alfa 3 times weekly /once weekly', 'type': 'DRUG', 'otherNames': ['PROCRIT'], 'description': 'Epoetin alfa will be administered as a SC injections at initial dose of 50 IU/kg (3 times weekly for 22 weeks) and at initial dose of 10000 IU (once weekly for 22 weeks)', 'armGroupLabels': ['TIW: Epoetin alfa 3 injections Weekly/Once Weekly']}, {'name': 'Epoetin alfa once weekly', 'type': 'DRUG', 'otherNames': ['PROCRIT'], 'description': 'Epoetin alfa will be administered as a SC injection at initial dose of 10000 IU (once weekly for 44 weeks).', 'armGroupLabels': ['QW: Epoetin alfa once weekly']}, {'name': 'Epoetin alfa once every two weeks', 'type': 'DRUG', 'otherNames': ['PROCRIT'], 'description': 'Epoetin alfa will be administered as a SC injection at initial dose of 20000 IU (once every 2 weeks for 44 weeks).', 'armGroupLabels': ['Q2W: Epoetin alfa once every two weeks']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Lynwood', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.93029, 'lon': -118.21146}}, {'city': 'Riverside', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Visalia', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.33023, 'lon': -119.29206}}, {'city': 'Whittier', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'city': 'Yuba City', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 39.14045, 'lon': -121.61691}}, {'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'city': 'Thornton', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.86804, 'lon': -104.97192}}, {'city': 'Lauderdale Lakes', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.16647, 'lon': -80.20838}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Zephyrhills', 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