Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-01 @ 8:25 AM
Study NCT ID:
NCT03762850
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2018-11-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634424', 'term': 'sparsentan'}, {'id': 'D000077405', 'term': 'Irbesartan'}, {'id': 'C529054', 'term': 'dapagliflozin'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@travere.com', 'phone': '1-877-659-5518', 'title': 'Travere Therapeutics Call Center', 'organization': 'Travere Therapeutics, Inc'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 114', 'description': 'Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Sparsentan', 'description': 'Participants randomized to Sparsentan received initial dose of 200 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).', 'otherNumAtRisk': 202, 'deathsNumAtRisk': 202, 'otherNumAffected': 187, 'seriousNumAtRisk': 202, 'deathsNumAffected': 0, 'seriousNumAffected': 75}, {'id': 'EG001', 'title': 'Irbesartan', 'description': 'Participants randomized to Irbesartan received initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).', 'otherNumAtRisk': 202, 'deathsNumAtRisk': 202, 'otherNumAffected': 177, 'seriousNumAtRisk': 202, 'deathsNumAffected': 1, 'seriousNumAffected': 71}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 15}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 28}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cellulitis orbital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Complicated appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Latent tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ludwig angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'IgA nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Glomerulonephritis rapidly progressive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Perinephric collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mechanical ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rectal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Brain contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperglycaemic hyperosmolar nonketotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abortion missed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Drug reaction with eosinophilia and systemic symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Target skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sparsentan', 'description': 'Participants randomized to Sparsentan received initial dose of 200 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).'}, {'id': 'OG001', 'title': 'Irbesartan', 'description': 'Participants randomized to Irbesartan received initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).'}], 'classes': [{'categories': [{'measurements': [{'value': '-49.77', 'groupId': 'OG000', 'lowerLimit': '-54.98', 'upperLimit': '-43.95'}, {'value': '-15.05', 'groupId': 'OG001', 'lowerLimit': '-23.72', 'upperLimit': '-5.39'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.69', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and at Week 36', 'description': "24-hour urine sample was collected for analysis of UP/C via a mixed-model repeated-measures (MMRM) analysis. Missing responses were imputed prior to analysis using multiple imputation. Change from Baseline during the double-blind period in UP/C on the log scale was the dependent variable. Log Baseline UP/C was included as a covariate along with fixed effects for randomized treatment, time (ie, nominal visit in weeks), randomized treatment-by-time interaction, and randomization strata with participants as random effect. Estimates in log scale were back transformed. Baseline was defined as the last non-missing observation on or prior to the start of the dosing. Using Rubin's approach, estimated treatment effects are combined across all imputations to obtain overall estimates.", 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary Analysis Set (PAS) is the subset of the Full Analysis Set at the time of the data extraction for primary analysis. Participants in the PAS were analyzed according to randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Total Slope of Estimated Glomerular Filtration Rate (eGFR) Over a 110-week Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sparsentan', 'description': 'Participants randomized to Sparsentan received initial dose of 200 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).'}, {'id': 'OG001', 'title': 'Irbesartan', 'description': 'Participants randomized to Irbesartan received initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.9', 'groupId': 'OG000', 'lowerLimit': '-3.58', 'upperLimit': '-2.24'}, {'value': '-3.9', 'groupId': 'OG001', 'lowerLimit': '-4.59', 'upperLimit': '-3.13'}]}]}], 'analyses': [{'pValue': '0.0582', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '1.94', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Day 1 to Week 110', 'description': "The rate of change in eGFR from Day 1 to Week 110 (ie, over 110 weeks) was analyzed via a mixed-model random coefficients analysis. Missing responses were imputed prior to analysis using multiple imputation. Fixed effects for randomized treatment, Baseline eGFR, time (in weeks), randomized treatment-by-time interaction, and randomization strata were included. In addition, the model also included a random intercept and random slope for each participant. Using Rubin's approach, the estimated treatment effects are combined across all imputations to obtain the overall estimates.", 'unitOfMeasure': 'milliliters/minute/1.73square meter/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Annualized Slope of eGFR Following the Initial Acute Effect of Randomized Treatment (Chronic Slope)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sparsentan', 'description': 'Participants randomized to Sparsentan received initial dose of 200 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).'}, {'id': 'OG001', 'title': 'Irbesartan', 'description': 'Participants randomized to Irbesartan received initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'groupId': 'OG000', 'lowerLimit': '-3.43', 'upperLimit': '-2.05'}, {'value': '-3.8', 'groupId': 'OG001', 'lowerLimit': '-4.60', 'upperLimit': '-3.07'}]}]}], 'analyses': [{'pValue': '0.0369', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.07', 'ciUpperLimit': '2.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Week 6 to Week 110 post randomization', 'description': "The rate of change in eGFR from Week 6 to Week 110 (ie, over 104 weeks following the initial acute effect of randomized therapy) was analyzed via a mixed-model random coefficients analysis. Missing responses were imputed prior to analysis using multiple imputation. Fixed effects for randomized treatment, Baseline eGFR, time (in weeks), randomized treatment-by-time interaction, and randomization strata were included. In addition, the model also included a random intercept and random slope for each participant. Using Rubin's approach, the estimated treatment effects are combined across all imputations to obtain the overall estimates.", 'unitOfMeasure': 'milliliters/minute/1.73square meter/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sparsentan', 'description': 'Participants randomized to Sparsentan received an initial dose of 200 milligrams (mg) (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of adverse events (AEs) or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).'}, {'id': 'FG001', 'title': 'Irbesartan', 'description': 'Participants randomized to Irbesartan received an initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '203'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}, {'groupId': 'FG001', 'numSubjects': '202'}]}, {'type': 'COMPLETED', 'comment': 'The participant flow presented is based on the double-blind period of the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '191'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'The PROTECT study is a 114-week, randomized, multicenter, double-blind (DB), parallel-group, active control study, in participants with Immunoglobulin A nephropathy (IgAN) who had persistent overt proteinuria and remained at high risk of disease progression despite being on a stable dose (or doses) of an Angiotensin converting enzyme inhibitor (ACEI) and/or Angiotensin II receptor blocker (ARB) that was (were) a maximum tolerated dose', 'preAssignmentDetails': 'The study was conducted across 3 regions (North America, Europe, and Asia Pacific), 18 countries, and 156 sites. The results presented are based on the double-blind period of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sparsentan', 'description': 'Participants randomized to Sparsentan received an initial dose of 200 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).'}, {'id': 'BG001', 'title': 'Irbesartan', 'description': 'Participants randomized to Irbesartan received an initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'spread': '12.76', 'groupId': 'BG000'}, {'value': '45.4', 'spread': '12.12', 'groupId': 'BG001'}, {'value': '46.0', 'spread': '12.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '368', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set comprised of all participants who were randomized and received at least 1 dose of randomized therapy'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-22', 'size': 2359486, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-27T10:26', 'hasProtocol': True}, {'date': '2021-07-21', 'size': 873730, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-27T10:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 406}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2018-11-27', 'resultsFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2018-11-30', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-11', 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36', 'timeFrame': 'Baseline (Day 1) and at Week 36', 'description': "24-hour urine sample was collected for analysis of UP/C via a mixed-model repeated-measures (MMRM) analysis. Missing responses were imputed prior to analysis using multiple imputation. Change from Baseline during the double-blind period in UP/C on the log scale was the dependent variable. Log Baseline UP/C was included as a covariate along with fixed effects for randomized treatment, time (ie, nominal visit in weeks), randomized treatment-by-time interaction, and randomization strata with participants as random effect. Estimates in log scale were back transformed. Baseline was defined as the last non-missing observation on or prior to the start of the dosing. Using Rubin's approach, estimated treatment effects are combined across all imputations to obtain overall estimates."}], 'secondaryOutcomes': [{'measure': 'Total Slope of Estimated Glomerular Filtration Rate (eGFR) Over a 110-week Period', 'timeFrame': 'From Day 1 to Week 110', 'description': "The rate of change in eGFR from Day 1 to Week 110 (ie, over 110 weeks) was analyzed via a mixed-model random coefficients analysis. Missing responses were imputed prior to analysis using multiple imputation. Fixed effects for randomized treatment, Baseline eGFR, time (in weeks), randomized treatment-by-time interaction, and randomization strata were included. In addition, the model also included a random intercept and random slope for each participant. Using Rubin's approach, the estimated treatment effects are combined across all imputations to obtain the overall estimates."}, {'measure': 'Annualized Slope of eGFR Following the Initial Acute Effect of Randomized Treatment (Chronic Slope)', 'timeFrame': 'From Week 6 to Week 110 post randomization', 'description': "The rate of change in eGFR from Week 6 to Week 110 (ie, over 104 weeks following the initial acute effect of randomized therapy) was analyzed via a mixed-model random coefficients analysis. Missing responses were imputed prior to analysis using multiple imputation. Fixed effects for randomized treatment, Baseline eGFR, time (in weeks), randomized treatment-by-time interaction, and randomization strata were included. In addition, the model also included a random intercept and random slope for each participant. Using Rubin's approach, the estimated treatment effects are combined across all imputations to obtain the overall estimates."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immunoglobulin A Nephropathy']}, 'referencesModule': {'references': [{'pmid': '38299639', 'type': 'DERIVED', 'citation': 'Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.'}, {'pmid': '37931634', 'type': 'DERIVED', 'citation': 'Rovin BH, Barratt J, Heerspink HJL, Alpers CE, Bieler S, Chae DW, Diva UA, Floege J, Gesualdo L, Inrig JK, Kohan DE, Komers R, Kooienga LA, Lafayette R, Maes B, Malecki R, Mercer A, Noronha IL, Oh SW, Peh CA, Praga M, Preciado P, Radhakrishnan J, Rheault MN, Rote WE, Tang SCW, Tesar V, Trachtman H, Trimarchi H, Tumlin JA, Wong MG, Perkovic V; DUPRO steering committee and PROTECT Investigators. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial. Lancet. 2023 Dec 2;402(10417):2077-2090. doi: 10.1016/S0140-6736(23)02302-4. Epub 2023 Nov 3.'}, {'pmid': '37254256', 'type': 'DERIVED', 'citation': 'Obadina M, Wilson S, Derebail VK, Little J. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations. Kidney360. 2023 Jul 1;4(7):997-1005. doi: 10.34067/KID.0000000000000162. Epub 2023 May 31.'}, {'pmid': '37015244', 'type': 'DERIVED', 'citation': 'Heerspink HJL, Radhakrishnan J, Alpers CE, Barratt J, Bieler S, Diva U, Inrig J, Komers R, Mercer A, Noronha IL, Rheault MN, Rote W, Rovin B, Trachtman H, Trimarchi H, Wong MG, Perkovic V; PROTECT Investigators. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. Lancet. 2023 May 13;401(10388):1584-1594. doi: 10.1016/S0140-6736(23)00569-X. Epub 2023 Apr 1.'}], 'seeAlsoLinks': [{'url': 'http://travere.com', 'label': 'Sponsor Website'}]}, 'descriptionModule': {'briefSummary': 'To determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).', 'detailedDescription': 'This is a 114-week,randomized, multicenter, double-blind, parallel-group, active-control study with an open-label extension period of up to 156 weeks, for a total duration of up to 270 weeks in patients with IgAN who have persistent overt proteinuria and remain at high risk of disease progression despite being on a stable dose (or doses) of an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) that is (are) a maximum tolerated dose that is at least one half of the maximum labeled dose (MLD) (according to approved labeling. Approximately 380 patients aged ≥18 years will be enrolled in the study globally. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor antagonist. The active control is irbesartan.\n\nThe purpose of the study is to evaluate the potential benefit of sparsentan on kidney function by analyzing change in proteinuria (protein in urine) and estimated glomerular filtration rate (eGFR) as compared to current standard treatment.\n\nPatients enrolled in the PROTECT study (Protocol 021IGAN17001) will be those at high risk of progressing to renal failure. They will be randomly assigned in a 1:1 ratio to either sparsentan or irbesartan, as the active control (current standard treatment) at the Day 1 (Randomization) visit. Study medication (sparsentan and irbesartan) will be administered as a single oral morning dose.\n\nThe primary analysis is change in proteinuria (urine protein/creatinine ratio) from baseline at Week 36 in sparsentan-treated patients as compared to irbesartan-treated patients.\n\nPrimary completion date represents the anticipated completion date of the double-blind portion of the study. Study completion date represents the anticipated completion date of the open-label extension portion of the study.\n\nPatients participating in the open-label extension period may be evaluated for eligibility to participate in a randomized, open-label, controlled Sub study evaluating the safety and efficacy of an SGLT2 inhibitor in addition to stable sparsentan treatment (OLE Sub study). The SGLT2 inhibitor, dapagliflozin will be provided as "study medication" for the OLE Sub study. Following completion of the visit 12 weeks after the OLE baseline visit, eligible patients may receive open-label dapagliflozin for at least 12 weeks but up to 24 additional weeks, or through the end of the open-label extension period, whichever is shortest. Approximately 60 patients from the open-label extension period will be enrolled into the OLE Sub study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria for the Double-Blind Period:\n\n* Age 18 years or older at screening\n* Biopsy-proven primary IgAN\n* Proteinuria of ≥1 g/day at screening\n* eGFR ≥30 mL/min/1.73 m2 at screening\n* Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (maximum tolerated dose and at least one-half of the maximum labeled dose)\n* Systolic BP ≤150 mmHg and diastolic BP ≤100 mmHg at screening\n* Willing to undergo change in ACEI and/or ARB and anti-hypertensive medications\n* Agree to contraception\n\nKey Exclusion Criteria for the Double-Blind Period:\n\n* IgAN secondary to another condition\n* Presence of cellular glomerular crescents in \\>25% of glomeruli on renal biopsy (if biopsy available within 6 months of screening)\n* Chronic kidney disease (CKD) in addition to IgAN\n* History of organ transplantation, with exception of corneal transplants\n* Require any prohibited medications\n* Treatment of systemic immunosuppressive medications (including corticosteroids) for \\>2 weeks within 3 months of screening\n* History of heart failure or previous hospitalization for heart failure or unexplained dyspnea, orthopnea, paroxysmal nocturnal dyspnea, ascites, and/or peripheral edema\n* Clinically significant cerebrovascular disease or coronary artery disease within 6 months of screening\n* Jaundice, hepatitis, or known hepatobiliary disease or elevations of transaminases (ALT/AST) \\>2 times upper limit of normal at screening\n* History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years\n* Hematocrit value \\<27% (0.27 V/V) or hemoglobin value \\<9 g/dL (90 g/L) at Screening\n* Potassium \\>5.5 mEq/L (5.5 mmol/L) at Screening\n* History of alcohol of illicit drug use disorder\n* History of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist, including sparsentan or irbesartan, or has a hypersensitivity to any of the excipients in the study medications\n* For female: Pregnancy, or planning to become pregnant during the course of the study, or breastfeeding\n* Participation in a study of another investigational product within 28 days of screening\n\nKey Inclusion Criteria for the Open-Label Extension Period based on assessments at the Week 110 visit:\n\n* Completed participation in the double-blind period, including the Week 114 visit\n* Did not permanently discontinue study medication during the double-blind period\n* Agree to contraception\n\nKey Exclusion Criteria for the Open-Label Extension Period based on assessments at the Week 110 and Week 114 visits:\n\n* Progression to end-stage renal disease (ESRD) requiring renal replacement therapy (RRT)\n* Development of any criteria for discontinuation of study medication or discontinuation from the study, between Week 110 and Week 114\n* Patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 110 and Week 114\n* eGFR ≤20 mL/min/1.73 m2 at Week 110\n* Female patient is pregnant or breastfeeding\n\nKey Inclusion Criteria for the OLE Sparsentan + SGLT2 Inhibitor Sub study:\n\n* Participating in the open-label extension and is willing and able to provide signed informed consent for participation in the open-label extension period Sub study\n* A urine protein excretion value of ≥0.3 g/day.\n* An eGFR of ≥25 mL/min/1.73m2\n* On a stable dose of sparsentan for ≥8 weeks in the open-label extension period that is the maximum tolerated dose.\n\nKey Exclusion Criteria for the OLE Sparsentan + SGLT2 Inhibitor Sub study:\n\n* Progressed to ESRD requiring RRT\n* Initiated or changed dose of a systemic immunosuppressive medication (including systemic steroids) within 12 weeks\n* Taking an SGLT2 inhibitor within 12 weeks'}, 'identificationModule': {'nctId': 'NCT03762850', 'acronym': 'PROTECT', 'briefTitle': 'A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Travere Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy', 'orgStudyIdInfo': {'id': '021IGAN17001'}, 'secondaryIdInfos': [{'id': '2017-004605-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sparsentan', 'description': 'Double-blind: Sparsentan will be administered daily as a 200-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 200 mg after 2 weeks will increase their dose to 400- mg and continue treatment to Week 110.', 'interventionNames': ['Drug: sparsentan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'irbesartan', 'description': 'Double-blind: Irbesartan will be administered daily as a 150-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg and continue treatment to Week 110.', 'interventionNames': ['Drug: irbesartan']}, {'type': 'EXPERIMENTAL', 'label': 'dapagliflozin + sparsentan (Sub study)', 'description': 'OLE Sub study: Dapagliflozin will be administered daily as a 5-mg oral tablet, in addition to 400-mg of Sparsentan, for a period of 12 weeks.', 'interventionNames': ['Drug: sparsentan', 'Drug: Dapagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'sparsentan (Sub Study)', 'description': 'OLE Sub study: Sparsentan will be administered daily as a dose of 400-mg for a period of 12 weeks.', 'interventionNames': ['Drug: sparsentan']}], 'interventions': [{'name': 'sparsentan', 'type': 'DRUG', 'otherNames': ['RE-021'], 'description': 'Target dose of 400 mg daily', 'armGroupLabels': ['dapagliflozin + sparsentan (Sub study)', 'sparsentan', 'sparsentan (Sub Study)']}, {'name': 'irbesartan', 'type': 'DRUG', 'otherNames': ['Irbesartan Tablets USP'], 'description': 'Target dose of 300 mg daily', 'armGroupLabels': ['irbesartan']}, {'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'Target dose of 10 mg daily', 'armGroupLabels': ['dapagliflozin + sparsentan (Sub study)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35209', 'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '90640', 'city': 'Montebello', 'state': 'California', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 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