Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-11 @ 3:03 AM
Study NCT ID:
NCT03301467
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2017-09-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Controlled Trial Evaluating Avacopan in C3 Glomerulopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015432', 'term': 'Glomerulonephritis, Membranoproliferative'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000620232', 'term': 'avacopan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@chemocentryx.com', 'phone': '650.210.2900', 'title': 'Clinical trial disclosure', 'organization': 'ChemoCentryx, Inc.'}, 'certainAgreement': {'otherDetails': 'The PI shall provide Sponsor with an advance copy of any proposed publication or oral presentation at least 60 days prior to the planned date of submission or presentation and Sponsor shall have 60 days to review the proposed publication. Sponsor may request in writing, and the PI shall agree to, (a) the deletion of any Confidential Information, (b) any reasonable changes requested by Sponsor, or (c) a delay of such proposed submission for an additional period, not to exceed 90 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From day 1 throughout the study period (day 182/week 26)', 'description': 'An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered\n\nThe safety population included all subjects who were randomized and had received at least one dose of study drug.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 24, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered\n\nThe safety population included all subjects who were randomized and had received at least one dose of study drug.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 25, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neutropenic sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bacterial parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': "Sjogren's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '0.4'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-2.3', 'upperLimit': '0.4'}]}]}], 'analyses': [{'pValue': '0.9670', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '1.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.\n\nC3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.\n\nC3G=C3 glomerulopathy', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Combined C5b-9 Strata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'categories': [{'measurements': [{'value': '26.20', 'spread': '47.302', 'groupId': 'OG000'}, {'value': '-5.77', 'spread': '5.904', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3083', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.02', 'estimateComment': "Test for normality showed that mean change and mean percent change were not normally distributed. As per SAP, Van Elteren's test was then applied to test mean percent change.\n\nSAP=Statistical Analysis Protocol", 'statisticalMethod': "Van Elteren's Test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 26', 'description': 'Percent change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.\n\nC3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.\n\nC3G=C3 glomerulopathy\n\n\\* Multiple Imputation: Missing Week 26 values are imputed using the regression method to create 100 complete datasets.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Subjects With Elevated C5b-9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Non-Responder', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4591', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel chi square general association statistic'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26', 'description': 'Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.\n\nC3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.\n\nC3G=C3 glomerulopathy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with C3G Histological Index of Disease Activity Percent Change at Week 26 is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Combined C5b-9 Strata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Non-Responder', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3106', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel chi square general association statistic'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26', 'description': 'Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.\n\nC3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.\n\nC3G=C3 glomerulopathy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with C3G Histological Index of Disease Activity Percent Change at Week 26 is reported.\n\nThe ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Subjects With Elevated C5b-9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '2.2'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1.8'}]}]}], 'analyses': [{'pValue': '0.3368', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.\n\nC3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement.\n\nC3G=C3 glomerulopathy', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Combined C5b-9 Strata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '2.2'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.4'}]}]}], 'analyses': [{'pValue': '0.0401', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-0.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.\n\nC3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement.\n\nC3G=C3 glomerulopathy', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.73', 'groupId': 'OG000', 'lowerLimit': '-12.29', 'upperLimit': '2.83'}, {'value': '6.11', 'groupId': 'OG001', 'lowerLimit': '-1.86', 'upperLimit': '14.08'}]}]}], 'analyses': [{'pValue': '0.0534', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.84', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '21.85', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.', 'unitOfMeasure': 'Percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.88', 'groupId': 'OG000', 'lowerLimit': '-12.32', 'upperLimit': '0.56'}, {'value': '4.79', 'groupId': 'OG001', 'lowerLimit': '-1.66', 'upperLimit': '11.23'}]}]}], 'analyses': [{'pValue': '0.0221', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.67', 'ciLowerLimit': '1.56', 'ciUpperLimit': '19.78', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.', 'unitOfMeasure': 'Percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.57', 'groupId': 'OG000', 'lowerLimit': '-8.43', 'upperLimit': '1.29'}, {'value': '0.44', 'groupId': 'OG001', 'lowerLimit': '-4.69', 'upperLimit': '5.56'}]}]}], 'analyses': [{'pValue': '0.2638', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.00', 'ciLowerLimit': '-3.08', 'ciUpperLimit': '11.08', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.35', 'groupId': 'OG000', 'lowerLimit': '-7.56', 'upperLimit': '0.85'}, {'value': '0.47', 'groupId': 'OG001', 'lowerLimit': '-3.75', 'upperLimit': '4.68'}]}]}], 'analyses': [{'pValue': '0.2069', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.82', 'ciLowerLimit': '-2.14', 'ciUpperLimit': '9.77', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Subjects With Elevated C5b-9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'categories': [{'measurements': [{'value': '-14', 'groupId': 'OG000', 'lowerLimit': '-34', 'upperLimit': '12'}, {'value': '-16', 'groupId': 'OG001', 'lowerLimit': '-36', 'upperLimit': '12'}]}]}], 'analyses': [{'pValue': '0.9284', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM UPCR Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.45', 'estimateComment': 'LSM UPCR Ratio Week 26 vs Baseline, Avacopan:Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (\\>= 0.15 g/g) - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.\n\nLSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio', 'unitOfMeasure': 'Percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Combined C5b-9 Strata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'categories': [{'measurements': [{'value': '-14', 'groupId': 'OG000', 'lowerLimit': '-33', 'upperLimit': '10'}, {'value': '-26', 'groupId': 'OG001', 'lowerLimit': '-42', 'upperLimit': '-6'}]}]}], 'analyses': [{'pValue': '0.3778', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM UPCR Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.21', 'estimateComment': 'LSM UPCR Ratio Week 26 vs Baseline, Avacopan:Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (\\>= 0.15 g/g) - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.\n\nLSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio', 'unitOfMeasure': 'Percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Subjects With Elevated C5b-9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-18', 'upperLimit': '25'}, {'value': '-23', 'groupId': 'OG001', 'lowerLimit': '-39', 'upperLimit': '-4'}]}]}], 'analyses': [{'pValue': '0.0810', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM MCP-1 Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.04', 'estimateComment': 'LSM MCP-1 Ratio Week 26 vs Baseline, Avacopan:Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.\n\nLSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1', 'unitOfMeasure': 'Percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Combined C5b-9 Strata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-17', 'upperLimit': '23'}, {'value': '-12', 'groupId': 'OG001', 'lowerLimit': '-28', 'upperLimit': '7'}]}]}], 'analyses': [{'pValue': '0.3233', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM MCP-1 Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.15', 'estimateComment': 'LSM MCP-1 Ratio Week 26 vs Baseline, Avacopan:Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.\n\nLSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1', 'unitOfMeasure': 'Percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects With Elevated C5b-9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'title': 'EQ-5D-5L VAS Score', 'categories': [{'measurements': [{'value': '-3.5', 'groupId': 'OG000', 'lowerLimit': '-7.8', 'upperLimit': '0.8'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-6.4', 'upperLimit': '2.7'}]}]}, {'title': 'EQ-5D-5L Index Score', 'categories': [{'measurements': [{'value': '0.0220', 'groupId': 'OG000', 'lowerLimit': '-0.0206', 'upperLimit': '0.0647'}, {'value': '-0.0202', 'groupId': 'OG001', 'lowerLimit': '-0.0653', 'upperLimit': '0.0249'}]}]}], 'analyses': [{'pValue': '0.6025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '7.9', 'groupDescription': 'EQ-5D-5L VAS Score', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}, {'pValue': '0.1797', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0422', 'ciLowerLimit': '-0.1043', 'ciUpperLimit': '0.0198', 'groupDescription': 'EQ-5D-5L Index Score', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.\n\nEQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'title': 'EQ-5D-5L VAS Score', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-3.9', 'upperLimit': '4.2'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '2.2'}]}]}, {'title': 'EQ-5D-5L Index Score', 'categories': [{'measurements': [{'value': '0.0060', 'groupId': 'OG000', 'lowerLimit': '-0.0334', 'upperLimit': '0.0454'}, {'value': '-0.0138', 'groupId': 'OG001', 'lowerLimit': '-0.0533', 'upperLimit': '0.0256'}]}]}], 'analyses': [{'pValue': '0.4898', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '3.8', 'groupDescription': 'EQ-5D-5L VAS Score', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}, {'pValue': '0.4826', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0199', 'ciLowerLimit': '-0.0757', 'ciUpperLimit': '0.0360', 'groupDescription': 'EQ-5D-5L Index Score', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.\n\nEQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'title': 'SF-36v2: Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8518', 'groupId': 'OG000', 'lowerLimit': '-3.2409', 'upperLimit': '8.9446'}, {'value': '3.2197', 'groupId': 'OG001', 'lowerLimit': '-3.3108', 'upperLimit': '9.7502'}]}]}, {'title': 'SF-36v2: Role-Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.2592', 'groupId': 'OG000', 'lowerLimit': '-11.5984', 'upperLimit': '3.0801'}, {'value': '3.5162', 'groupId': 'OG001', 'lowerLimit': '-4.2634', 'upperLimit': '11.2958'}]}]}, {'title': 'SF-36v2: Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '-4.2', 'upperLimit': '11.4'}, {'value': '-3.5', 'groupId': 'OG001', 'lowerLimit': '-12.0', 'upperLimit': '4.9'}]}]}, {'title': 'SF-36v2: General Health Perceptions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '5.2'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '-4.8', 'upperLimit': '8.0'}]}]}, {'title': 'SF-36v2: Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.472', 'groupId': 'OG000', 'lowerLimit': '-8.906', 'upperLimit': '3.963'}, {'value': '3.898', 'groupId': 'OG001', 'lowerLimit': '-2.978', 'upperLimit': '10.774'}]}]}, {'title': 'SF-36v2: Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.58', 'groupId': 'OG000', 'lowerLimit': '-2.30', 'upperLimit': '11.47'}, {'value': '0.34', 'groupId': 'OG001', 'lowerLimit': '-7.20', 'upperLimit': '7.88'}]}]}, {'title': 'SF-36v2: Role-Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6859', 'groupId': 'OG000', 'lowerLimit': '-6.8507', 'upperLimit': '8.2225'}, {'value': '3.2461', 'groupId': 'OG001', 'lowerLimit': '-4.6899', 'upperLimit': '11.1821'}]}]}, {'title': 'SF-36v2: Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.423', 'groupId': 'OG000', 'lowerLimit': '-3.684', 'upperLimit': '8.530'}, {'value': '2.730', 'groupId': 'OG001', 'lowerLimit': '-3.791', 'upperLimit': '9.251'}]}]}, {'title': 'SF-36v2: Physical Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3257', 'groupId': 'OG000', 'lowerLimit': '-2.6090', 'upperLimit': '1.9576'}, {'value': '0.0762', 'groupId': 'OG001', 'lowerLimit': '-2.4423', 'upperLimit': '2.5947'}]}]}, {'title': 'SF-36v2: Mental Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7556', 'groupId': 'OG000', 'lowerLimit': '-2.3560', 'upperLimit': '3.8672'}, {'value': '0.7608', 'groupId': 'OG001', 'lowerLimit': '-2.6341', 'upperLimit': '4.1558'}]}]}], 'analyses': [{'pValue': '0.8161', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4019', 'ciLowerLimit': '-3.0402', 'ciUpperLimit': '3.8440', 'groupDescription': 'SF-36v2: Physical Component Score', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}, {'pValue': '0.9982', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0052', 'ciLowerLimit': '-4.5994', 'ciUpperLimit': '4.6099', 'groupDescription': 'SF-36v2: Mental Component Score', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Change from baseline over 26 weeks in SF-36 v2 - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.\n\nSF-36v2: Medical Outcomes Survey Short Form-36 version 2.\n\nSF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'title': 'SF-36v2: Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9619', 'groupId': 'OG000', 'lowerLimit': '-2.7150', 'upperLimit': '8.6389'}, {'value': '4.6532', 'groupId': 'OG001', 'lowerLimit': '-1.1123', 'upperLimit': '10.4187'}]}]}, {'title': 'SF-36v2: Role-Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4712', 'groupId': 'OG000', 'lowerLimit': '-9.6179', 'upperLimit': '4.6755'}, {'value': '1.2077', 'groupId': 'OG001', 'lowerLimit': '-5.9734', 'upperLimit': '8.3887'}]}]}, {'title': 'SF-36v2: Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '-5.7', 'upperLimit': '8.7'}, {'value': '-2.0', 'groupId': 'OG001', 'lowerLimit': '-9.3', 'upperLimit': '5.4'}]}]}, {'title': 'SF-36v2: General Health Perceptions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-6.6', 'upperLimit': '4.6'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '-4.9', 'upperLimit': '6.2'}]}]}, {'title': 'SF-36v2: Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.468', 'groupId': 'OG000', 'lowerLimit': '-6.283', 'upperLimit': '5.348'}, {'value': '4.085', 'groupId': 'OG001', 'lowerLimit': '-1.782', 'upperLimit': '9.952'}]}]}, {'title': 'SF-36v2: Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.66', 'groupId': 'OG000', 'lowerLimit': '-1.41', 'upperLimit': '10.73'}, {'value': '1.55', 'groupId': 'OG001', 'lowerLimit': '-4.66', 'upperLimit': '7.76'}]}]}, {'title': 'SF-36v2: Role-Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3024', 'groupId': 'OG000', 'lowerLimit': '-3.3147', 'upperLimit': '11.9195'}, {'value': '7.8375', 'groupId': 'OG001', 'lowerLimit': '0.2129', 'upperLimit': '15.4620'}]}]}, {'title': 'SF-36v2: Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.503', 'groupId': 'OG000', 'lowerLimit': '-3.911', 'upperLimit': '6.917'}, {'value': '3.914', 'groupId': 'OG001', 'lowerLimit': '-1.543', 'upperLimit': '9.370'}]}]}, {'title': 'SF-36v2: Physical Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3578', 'groupId': 'OG000', 'lowerLimit': '-2.5452', 'upperLimit': '1.8296'}, {'value': '-0.5096', 'groupId': 'OG001', 'lowerLimit': '-2.7680', 'upperLimit': '1.7489'}]}]}, {'title': 'SF-36v2: Mental Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3591', 'groupId': 'OG000', 'lowerLimit': '-1.7970', 'upperLimit': '4.5153'}, {'value': '2.3874', 'groupId': 'OG001', 'lowerLimit': '-0.8529', 'upperLimit': '5.6277'}]}]}], 'analyses': [{'pValue': '0.9242', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1518', 'ciLowerLimit': '-3.3192', 'ciUpperLimit': '3.0156', 'groupDescription': 'SF-36v2: Physical Component Score', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}, {'pValue': '0.6534', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0283', 'ciLowerLimit': '-3.4972', 'ciUpperLimit': '5.5537', 'groupDescription': 'SF-36v2: Mental Component Score', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Change from baseline over 26 weeks in SF-36 v2 - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.\n\nSF-36v2: Medical Outcomes Survey Short Form-36 version 2.\n\nSF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.\n\nITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'title': 'Number of subjects with at least one TEAE', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Number of subjects with SAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Number of subjects with TEAEs possibly related to Study Medication', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Number of subjects with TEAEs leading to discontinuation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From day 1 throughout the study period (day 182/week 26)', 'description': "Number of Subjects with Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs\n\nAEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'OG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'classes': [{'title': 'Number of TEAEs', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}, {'title': 'Number of SAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Number of TEAEs possibly related to Study Medication', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Number of TEAEs leading to discontinuation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From day 1 throughout the study period (day 182/week 26)', 'description': "Number of Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs\n\nAEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment", 'unitOfMeasure': 'Adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'FG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Group', 'description': 'Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period\n\nAvacopan-matching placebo: Orally administered'}, {'id': 'BG001', 'title': 'Avacopan Group', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period\n\nAvacopan: Orally administered'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37.2', 'spread': '17.53', 'groupId': 'BG000'}, {'value': '32.2', 'spread': '15.03', 'groupId': 'BG001'}, {'value': '34.7', 'spread': '16.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '12-17 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': '18-50 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': '51-65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': '>65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Ireland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Geographic Region', 'classes': [{'title': 'North America', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Rest of World', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age at Diagnosis of C3G', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.3', 'spread': '17.95', 'groupId': 'BG000'}, {'value': '28.2', 'spread': '17.08', 'groupId': 'BG001'}, {'value': '30.8', 'spread': '17.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'C3G=C3 Glomerulopathy', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'C3GN or DDD', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'title': 'C3GN', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'DDD', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'C3GN=C3 Glomerulonephritis; DDD=Dense Deposit\n\nMissing refers to one subject for whom disease type (C3GN vs DDD) could not be determined and subject was randomized in error.', 'unitOfMeasure': 'Participants'}, {'title': 'History of Kidney Transplant', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Missing refers to one subject for whom disease type (C3GN vs DDD) could not be determined and subject was randomized in error.', 'unitOfMeasure': 'Participants'}, {'title': 'C5b-9 Stratum', 'classes': [{'title': '> 244 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': '<= 244 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'C5b-9 levels \\<= 244 ng/mL were normal according to the central laboratory used for the study. Defined by assay normal range.', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of C3G', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '46.7', 'spread': '43.78', 'groupId': 'BG000'}, {'value': '48.2', 'spread': '46.38', 'groupId': 'BG001'}, {'value': '47.4', 'spread': '44.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Calculated from the time of first diagnosis based on renal biopsy. C3G=C3 glomerulopathy', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'eGFR', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72.34', 'spread': '43.509', 'groupId': 'BG000'}, {'value': '79.29', 'spread': '39.751', 'groupId': 'BG001'}, {'value': '75.75', 'spread': '41.480', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'eGFR=estimated Glomerular Filtration Rate', 'unitOfMeasure': 'mL/min/1.73m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'UPCR', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.80', 'spread': '2.435', 'groupId': 'BG000'}, {'value': '4.11', 'spread': '3.380', 'groupId': 'BG001'}, {'value': '3.44', 'spread': '2.985', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'UPCR=Urine Protein to Creatinine Ratio', 'unitOfMeasure': 'g/g', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'UPCR (g/g)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'title': '> 1 g/g', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': '<= 1 g/g', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'UPCR=Urine Protein to Creatinine Ratio\n\nUrine protein-to-creatinine ratio (UPCR): UPCR was calculated by dividing the level of protein in a spot urine test by the creatinine level. UPCR estimates the 24-hour protein excretion in grams per day and is used in clinical practice and clinical trials to measure the severity of proteinuria in patients.', 'unitOfMeasure': 'Participants'}, {'title': 'Urinary MCP-1:Creatinine Ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '750.29', 'spread': '492.542', 'groupId': 'BG000'}, {'value': '1215.88', 'spread': '1303.359', 'groupId': 'BG001'}, {'value': '978.85', 'spread': '997.191', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mg Creatinine', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '2 patients missed baseline Urinary MCP-1 data.'}, {'title': 'Body Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72.65', 'spread': '12.631', 'groupId': 'BG000'}, {'value': '78.33', 'spread': '19.229', 'groupId': 'BG001'}, {'value': '75.44', 'spread': '16.317', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram(s)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '171.41', 'spread': '8.773', 'groupId': 'BG000'}, {'value': '173.82', 'spread': '10.805', 'groupId': 'BG001'}, {'value': '172.60', 'spread': '9.810', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter(s)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24.65', 'spread': '3.410', 'groupId': 'BG000'}, {'value': '26.05', 'spread': '6.375', 'groupId': 'BG001'}, {'value': '25.34', 'spread': '5.090', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'BMI=Body Mass Index', 'unitOfMeasure': 'kilogram(s)/square meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'EQ-5D-5L Index Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.145', 'groupId': 'BG000'}, {'value': '0.87', 'spread': '0.116', 'groupId': 'BG001'}, {'value': '0.88', 'spread': '0.130', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'EQ-5D-5L=EuroQuality of Life-5 Domains-5 Levels\n\nThe EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'EQ-5D-5L VAS Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '78.83', 'spread': '20.604', 'groupId': 'BG000'}, {'value': '73.61', 'spread': '19.070', 'groupId': 'BG001'}, {'value': '76.26', 'spread': '19.862', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'EQ-5D-5L=EuroQuality of Life-5 Domains-5 Levels\n\nVAS=Visual Analog Scale\n\nThe EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D questionnaire includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Viral Test Results HIV-1/2 Antibody', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Reactive', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Non-reactive', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'HIV=Human Immunodeficiency Virus', 'unitOfMeasure': 'Participants'}, {'title': 'Viral Test Results - Hepatitis B Virus Surface Antigen', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Reactive', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Non-reactive', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Viral Test Results - Hepatitis C Virus Antibody', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Reactive', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Non-reactive', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-20', 'size': 1434003, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-05-19T08:55', 'hasProtocol': True}, {'date': '2020-11-05', 'size': 17464978, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-05-19T08:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Matching placebo'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo crossover to active'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2017-09-22', 'resultsFirstSubmitDate': '2022-05-19', 'studyFirstSubmitQcDate': '2017-09-29', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-12', 'studyFirstPostDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9', 'timeFrame': 'Week 26', 'description': 'Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.\n\nC3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.\n\nC3G=C3 glomerulopathy'}, {'measure': 'Percent Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Combined C5b-9 Strata', 'timeFrame': 'Week 26', 'description': 'Percent change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.\n\nC3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.\n\nC3G=C3 glomerulopathy\n\n\\* Multiple Imputation: Missing Week 26 values are imputed using the regression method to create 100 complete datasets.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Subjects With Elevated C5b-9', 'timeFrame': 'Week 26', 'description': 'Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.\n\nC3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.\n\nC3G=C3 glomerulopathy'}, {'measure': 'Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Combined C5b-9 Strata', 'timeFrame': 'Week 26', 'description': 'Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.\n\nC3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.\n\nC3G=C3 glomerulopathy'}, {'measure': 'Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Subjects With Elevated C5b-9', 'timeFrame': 'Week 26', 'description': 'Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.\n\nC3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement.\n\nC3G=C3 glomerulopathy'}, {'measure': 'Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Combined C5b-9 Strata', 'timeFrame': 'Week 26', 'description': 'Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.\n\nC3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement.\n\nC3G=C3 glomerulopathy'}, {'measure': 'Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9', 'timeFrame': 'Week 26', 'description': 'The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.'}, {'measure': 'Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata', 'timeFrame': 'Week 26', 'description': 'The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.'}, {'measure': 'Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9', 'timeFrame': 'Week 26', 'description': 'The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.'}, {'measure': 'Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata', 'timeFrame': 'Week 26', 'description': 'The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.'}, {'measure': 'Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Subjects With Elevated C5b-9', 'timeFrame': 'Week 26', 'description': 'Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (\\>= 0.15 g/g) - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.\n\nLSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio'}, {'measure': 'Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Combined C5b-9 Strata', 'timeFrame': 'Week 26', 'description': 'Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (\\>= 0.15 g/g) - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.\n\nLSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio'}, {'measure': 'Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Subjects With Elevated C5b-9', 'timeFrame': 'Week 26', 'description': 'Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.\n\nLSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1'}, {'measure': 'Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Combined C5b-9 Strata', 'timeFrame': 'Week 26', 'description': 'Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.\n\nLSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1'}, {'measure': 'Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects With Elevated C5b-9', 'timeFrame': 'Week 26', 'description': 'Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.\n\nEQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).'}, {'measure': 'Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata', 'timeFrame': 'Week 26', 'description': 'Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.\n\nEQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).'}, {'measure': 'Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9', 'timeFrame': 'Week 26', 'description': 'Change from baseline over 26 weeks in SF-36 v2 - Subjects with Elevated C5b-9 (\\> 244 ng/mL) in the Intent-to-Treat Population.\n\nSF-36v2: Medical Outcomes Survey Short Form-36 version 2.\n\nSF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).'}, {'measure': 'Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata', 'timeFrame': 'Week 26', 'description': 'Change from baseline over 26 weeks in SF-36 v2 - Combined C5b-9 Strata (elevated \\[\\> 244 ng/mL\\] and non-elevated C5b-9) in the Intent-to-Treat Population.\n\nSF-36v2: Medical Outcomes Survey Short Form-36 version 2.\n\nSF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).'}, {'measure': 'Number of Subjects With Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs', 'timeFrame': 'From day 1 throughout the study period (day 182/week 26)', 'description': "Number of Subjects with Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs\n\nAEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment"}, {'measure': 'Number of Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs', 'timeFrame': 'From day 1 throughout the study period (day 182/week 26)', 'description': "Number of Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs\n\nAEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['C3 Glomerulonephritis', 'C3 glomerulopathy', 'C3G', 'DDD', 'dense deposit disease', 'membranoproliferative glomerulonephritis', 'MPGN', 'C3GN', 'idiopathic MPGN'], 'conditions': ['C3 Glomerulopathy (C3G)']}, 'referencesModule': {'references': [{'pmid': '39392695', 'type': 'DERIVED', 'citation': 'Bomback AS, Herlitz LC, Kedia PP, Petersen J, Yue H, Lafayette RA; ACCOLADE Study Group. Safety and Efficacy of Avacopan in Patients with Complement 3 Glomerulopathy: Randomized, Double-Blind Clinical Trial. J Am Soc Nephrol. 2025 Mar 1;36(3):487-499. doi: 10.1681/ASN.0000000526. Epub 2024 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to evaluate the effect of avacopan treatment on renal disease activity in patients with complement component 3 glomerulopathy (C3G). Funding Source - FDA OOPD', 'detailedDescription': 'C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD) and C3 glomerulonephritis (C3GN). There is no approved treatment for patients with C3G.\n\nThis is a randomized, double blind, placebo controlled Phase 2 study to evaluate the safety and efficacy of avacopan (CCX168) in patients with C3G. Patients receive avacopan 30mg or matching placebo orally twice-daily. The placebo-controlled treatment period is 26 weeks (182 days). This will be followed by 26 weeks during which time all patients will receive avacopan (results for this second period will be reported in due course in a follow-up publication). Thereafter, all patients will be followed for eight weeks (56 days) without study drug treatment. The primary objective is to evaluate the efficacy of avacopan compared to placebo based on histologic changes in kidney biopsies taken at baseline and after 26 weeks of treatment. The primary endpoint will be based on the percent change from baseline in the C3G Histologic Index for disease activity.\n\nStudy acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Biopsy-proven C3G, either DDD or C3GN, with or without a renal transplant, and with the following observations upon renal biopsy taken within 12 weeks prior to screening or during screening:\n\n 1. ≥2-levels of magnitude greater staining of C3 than any combination of IgG, IgM, IgA, kappa and lambda light chains, and C1q by immunohistochemistry, and\n 2. evidence of proliferative glomerulonephritis (mesangial hypercellularity of greater than 3 mesangial cells per mesangial area and/or endocapillary hypercellularity defined as an increased number of cells within glomerular capillary lumina, causing luminal narrowing) based on light microscopy, and\n 3. confirmation of the presence of electron dense deposits in the glomeruli on electron microscopy corresponding with the C3 immunofluorescence positivity;\n2. Male or female subjects, aged at least 18 years; where approved, adolescents (12-17 year old) may be enrolled; female subjects of childbearing potential (i.e., those who have experienced menarche and who is not permanently sterile or postmenopausal, defined as at least 12 consecutive months with no menses without an alternative medical cause) may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the 3 months after study completion; Adequate contraception is defined as resulting in a failure rate of less than 1% per year (combined estrogen and progestogen \\[oral, intravaginal, or transdermal\\], or progestogen-only hormonal contraception (oral, injectable, or implantable), intra-uterine device, intra-uterine hormone releasing system, bilateral tubal occlusion, vasectomized partner, or true sexual abstinence, i.e., in line with the preferred and usual lifestyle of the subject);\n3. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol; written Assent and Informed Consent must be obtained from the legal guardian in accordance with regional laws or regulations for subjects 12 to 17 years of age; and\n4. Judged to be otherwise fit for the study by the Investigator, based on medical history, physical examination, and clinical laboratory assessments. Subjects with clinical laboratory values that are outside of normal limits (other than those specified in the Exclusion Criteria) and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance, may be entered into the study.\n\nExclusion Criteria:\n\n1. Pregnant or nursing;\n2. Tubulointerstitial fibrosis appears to be more than 50% based on standard assessment using trichrome staining of the renal biopsy;\n3. Use of eculizumab or another anti-C5 antibody within 26 weeks prior to dosing;\n4. Secondary C3 disease, e.g., infection-associated disease, or associated with another systemic or autoimmune disease; presence of a monoclonal spike on serum or urine protein electrophoresis or immunofixation assay;\n5. Currently on dialysis or likely will require dialysis within 7 days after screening;\n6. History or presence of any form of cancer within the 5 years prior to screening, with the exception of excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ such as cervical or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis;\n7. Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) viral screening test indicative of acute or chronic infection;\n8. Evidence of tuberculosis based on interferon γ release assay (IGRA), tuberculin purified protein derivative (PPD) skin test, or chest radiography done at screening or within 6 weeks prior to screening;\n9. WBC count less than 3500/μL, or neutrophil count less than 1500/μL, or lymphocyte count less than 500/μL before start of dosing;\n10. Evidence of hepatic disease; AST, ALT, alkaline phosphatase, or bilirubin \\>3 x the upper limit of normal before start of dosing;\n11. Currently using a strong inducer of the CYP3A4 enzyme, such as carbamazepine, phenobarbital, phenytoin, rifampin, or St. John's wort;\n12. Known hypersensitivity to avacopan or inactive ingredients of the avacopan capsules (including gelatin, polyethylene glycol, or Cremophor) or inability to swallow the capsules;\n13. Participated in any clinical study of an investigational product within 30 days prior to screening or within 5 half-lives after taking the last dose; and\n14. History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation."}, 'identificationModule': {'nctId': 'NCT03301467', 'acronym': 'ACCOLADE', 'briefTitle': 'Controlled Trial Evaluating Avacopan in C3 Glomerulopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients With C3 Glomerulopathy', 'orgStudyIdInfo': {'id': 'CL011_168'}, 'secondaryIdInfos': [{'id': '1R01FD006342-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01FD006342-01', 'type': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Avacopan', 'description': 'Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period', 'interventionNames': ['Drug: Avacopan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Avacopan Matching Placebo', 'description': 'Matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period', 'interventionNames': ['Drug: Avacopan Matching Placebo']}], 'interventions': [{'name': 'Avacopan', 'type': 'DRUG', 'otherNames': ['CCX168'], 'description': 'Orally administered', 'armGroupLabels': ['Avacopan']}, {'name': 'Avacopan Matching Placebo', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'avacopan matching placebo', 'armGroupLabels': ['Avacopan Matching Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 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{'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Clinical Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Burela de Cabo', 'country': 'Spain', 'facility': 'Clinical Site', 'geoPoint': {'lat': 43.662, 'lon': -7.367}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Clinical Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Clinical Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Clinical Site', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'http://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medpace, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}