Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 4:34 AM
Study NCT ID:
NCT05856760
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2023-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}}}}, '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'}]}}, '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': '525 Days (1 year, 5 months, and 6 days) Continuous monitoring from Day -42 (screening) to Week 28 (safety follow-up visit)', 'eventGroups': [{'id': 'EG000', 'title': 'Sparsentan', 'description': 'Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.\n\nSparsentan: Target dose of 400 mg daily', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 26, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebrovascular event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chemical burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sparsentan', 'description': 'Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.\n\nSparsentan: Target dose of 400 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.78', 'groupId': 'OG000', 'lowerLimit': '-65.8', 'upperLimit': '-42.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': 'The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'UA/C <0.2 g/g at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sparsentan', 'description': 'Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.\n\nSparsentan: Target dose of 400 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '47.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Achievement of UA/C of \\<0.2 g/g at Week 24 based on FMV samples', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': '30% Reduction From Baseline in UA/C at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sparsentan', 'description': 'Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.\n\nSparsentan: Target dose of 400 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '60.7', 'upperLimit': '88.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Achievement of 30% reduction from baseline in UA/C at Week 24 based on FMV samples', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'UA/C Responder Endpoints While on Treatment'}, {'type': 'SECONDARY', 'title': '50% Reduction From Baseline in UA/C at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sparsentan', 'description': 'Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.\n\nSparsentan: Target dose of 400 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000', 'lowerLimit': '34.8', 'upperLimit': '67.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Achievement of 50% reduction from baseline in UA/C at Week 24 based on FMV samples', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change in Urine Protein-to-creatinine Ratio (UP/C) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sparsentan', 'description': 'Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.\n\nSparsentan: Target dose of 400 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.20', 'groupId': 'OG000', 'lowerLimit': '-54.6', 'upperLimit': '-33.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': 'The change from baseline in UP/C at Week 24 based on FMV samples', 'unitOfMeasure': 'percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Estimated Glomerular Filtration Rate (eGFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sparsentan', 'description': 'Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.\n\nSparsentan: Target dose of 400 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-3.9', 'upperLimit': '-0.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 24', 'description': 'Change from baseline estimated glomerular filtration rate at 24 weeks', 'unitOfMeasure': 'mL/min/1.73 square meter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure (BP) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sparsentan', 'description': 'Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.\n\nSparsentan: Target dose of 400 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'groupId': 'OG000', 'lowerLimit': '-6.8', 'upperLimit': '0.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': 'The change from baseline in systolic BP at Week 24', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure (BP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sparsentan', 'description': 'Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.\n\nSparsentan: Target dose of 400 mg daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.6', 'groupId': 'OG000', 'lowerLimit': '-6.7', 'upperLimit': '-2.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': 'The change from baseline in diastolic BP at Week 24', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sparsentan', 'description': 'Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.\n\nSparsentan: Target dose of 400 mg daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'Discontinued', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Date of last participant visit.', 'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Forty-eight participants were enrolled in the study and all 48 (100%) received at least 1 dose of sparsentan.\n\nSparsentan was prematurely discontinued in 9 participants (19%).\n\nForty-one participants (85%) completed the study, and 7 participants (15%) discontinued the study. The most common reasons for discontinuation from the study were withdrawal by participant (3 participants \\[6%\\]) and AEs (2 participants \\[4%\\]).', 'preAssignmentDetails': '93 participants were screened; 45 participants were screen failures.\n\n* 29 participants did not meet the inclusion criteria of UA/C ≥0.3 g/g\n* 7 participants did not meet the inclusion criteria of being on a stable dose of ACEI and/or ARB\n* 5 participants did not meet the inclusion criteria of being on a stable dose of an SGLT2 inhibitor\n* 4 participants were excluded for other reasons'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sparsentan', 'description': 'Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.\n\nSparsentan: Target dose of 400 mg daily'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.2', 'spread': '11.16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '85.9', 'spread': '22.25', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '30.02', 'spread': '5.619', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Estimated Glomerular Filtration Rate (eGFR)', 'classes': [{'title': '<25 mL/min/1.73m^2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '>/=25 to <60 mL/min/173m^2', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': '>/=60 mL/min/1.73m^2', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Urine protein/creatinine ratio (UP/C)', 'classes': [{'categories': [{'measurements': [{'value': '1.29', 'groupId': 'BG000', 'lowerLimit': '0.3', 'upperLimit': '6.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'unitOfMeasure': 'g/g', 'dispersionType': 'FULL_RANGE'}, {'title': 'Urine albumin/creatinine ratio (UA/C)', 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'groupId': 'BG000', 'lowerLimit': '0.2', 'upperLimit': '4.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'unitOfMeasure': 'g/g', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-21', 'size': 1091449, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-07T14:42', 'hasProtocol': True}, {'date': '2024-06-20', 'size': 490071, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-07T14:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2023-05-03', 'resultsFirstSubmitDate': '2025-10-08', 'studyFirstSubmitQcDate': '2023-05-03', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-06', 'studyFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24', 'timeFrame': 'Week 24', 'description': 'The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples'}], 'secondaryOutcomes': [{'measure': 'UA/C <0.2 g/g at Week 24', 'timeFrame': 'Week 24', 'description': 'Achievement of UA/C of \\<0.2 g/g at Week 24 based on FMV samples'}, {'measure': '30% Reduction From Baseline in UA/C at Week 24', 'timeFrame': 'Week 24', 'description': 'Achievement of 30% reduction from baseline in UA/C at Week 24 based on FMV samples'}, {'measure': '50% Reduction From Baseline in UA/C at Week 24', 'timeFrame': 'Week 24', 'description': 'Achievement of 50% reduction from baseline in UA/C at Week 24 based on FMV samples'}, {'measure': 'Change in Urine Protein-to-creatinine Ratio (UP/C) at Week 24', 'timeFrame': 'Week 24', 'description': 'The change from baseline in UP/C at Week 24 based on FMV samples'}, {'measure': 'Estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': 'Week 24', 'description': 'Change from baseline estimated glomerular filtration rate at 24 weeks'}, {'measure': 'Systolic Blood Pressure (BP) at Week 24', 'timeFrame': 'Week 24', 'description': 'The change from baseline in systolic BP at Week 24'}, {'measure': 'Change in Diastolic Blood Pressure (BP)', 'timeFrame': 'Week 24', 'description': 'The change from baseline in diastolic BP at Week 24'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IgAN'], 'conditions': ['Immunoglobulin A Nephropathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://travere.com', 'label': 'Sponsor Website'}]}, 'descriptionModule': {'briefSummary': 'This was a 28-week, open-label, multicenter, single-group Phase 2 exploratory study to determine the safety and effect of sparsentan in participants with IgAN who are at risk of disease progression to kidney failure despite being on both stable RAASi and SGLT2 inhibitor treatment for at least 12 weeks prior to study entry', 'detailedDescription': 'This was a 28-week, open-label, multicenter, single-group Phase 2 exploratory study to determine the safety and effect of sparsentan in participants with Immunoglobulin A Nephropathy (IgAN) who are at risk of disease progression to kidney failure (KF) despite being on both stable renin angiotensin aldosterone system inhibitor (RAASi) and sodium glucose cotransporter-2 (SGLT2) inhibitor treatment for at least 12 weeks prior to study entry.\n\nParticipants who provided written informed consent were assessed for eligibility and underwent baseline evaluations including clinical laboratory tests. Per the eligibility criteria, all participants were required to be on a stable dose(s) of angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) and on a stable dose of a SGLT2 inhibitor at screening and continued their stable treatments through the screening period. Eligible participants discontinued ACEI and/or ARB therapy the day before the Day 1 visit and remained on stable SGLT2 inhibitor dosing for the duration of the study.\n\nStudy intervention was administered daily for a treatment period of 24 weeks with study visits conducted at weeks 2-, 4-, 12-, and 24- following Day 1. Following the 24-week treatment period, study intervention was discontinued for 4 weeks and standard of care RAASi treatment resumed, with a safety visit at Week 28.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged ≥18 years at the time of signing the informed consent.\n* Biopsy-proven IgAN. The biopsy may have been performed at any time in the past.\n* UA/C ≥0.3 g/g at screening\n* An eGFR value of ≥25 mL/min/1.73m\\^2 at screening.\n* On a stable dose of an SGLT2 inhibitor for at least 12 weeks prior to screening.\n* On a stable dose of ACEI and/or ARB therapy for at least 12 weeks prior to screening that is:\n\n * The participant's maximum tolerated dose (MTD), and\n * at least one half of the maximum labeled dose (MLD)\n* Systolic BP must be ≤160 mmHg, and diastolic BP must be ≤110 mmHg at screening.\n* For participants receiving chronic low dose systemic corticosteroids (defined as ≤10 mg/day prednisone or equivalent), or an enteric formulation of budesonide and/or a mineralocorticoid receptor antagonist (MRA), the dosage must be stable for ≥12 weeks prior to screening.\n\nExclusion Criteria:\n\n* IgAN secondary to another condition or immunoglobulin A (IgA) vasculitis.\n* Undergone any organ transplant, with the exception of corneal transplants.\n* Documented history of heart failure.\n* Taking high dose (defined as \\>10 mg/day prednisone) or other any systemic immunosuppressive medications within 12 weeks of prior to screening.\n* Has clinically significant cerebrovascular disease (transient ischemic attack or stroke) and/or coronary artery disease (hospitalization for myocardial infarction unstable angina, new onset of angina with positive functional tests, coronary angiogram revealing stenosis, or a coronary revascularization procedure) within 3 months prior to screening.\n* Has jaundice, hepatitis, or known hepatobiliary disease (excluding asymptomatic cholelithiasis), or ALT and/or AST \\>2 times the ULN range at screening.\n* Has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years.\n* Has a history of serious side effect or allergic response to any AngII antagonist, ERA or sparsentan, or has a hypersensitivity to any of the excipients in the study intervention.\n* Requires any of the prohibited concomitant medications.\n* Treatment with sparsentan within 12 weeks prior to screening\n* Has participated in a study of another investigational product within 28 days prior to screening or plans to participate in such a study during the course of this study.\n* Has a screening hematocrit value \\<27% (0.27 Volume/Volume) or hemoglobin value \\<9 g/dL (90 g/L).\n* Has a screening potassium value of \\>5.5 mEq/L (5.5 mmol/L).\n* Is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.\n* The participant, in the opinion of the Investigator, is unable to adhere to the requirements of the study, including the ability to swallow the study intervention capsules whole."}, 'identificationModule': {'nctId': 'NCT05856760', 'acronym': 'SPARTACUS', 'briefTitle': 'A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN', 'organization': {'class': 'INDUSTRY', 'fullName': 'Travere Therapeutics, Inc.'}, 'officialTitle': 'A Multicentered, Single-group Phase 2, Exploratory, Open-label Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in the Treatment of Adult Participants With Immunoglobulin A Nephropathy (IgAN)', 'orgStudyIdInfo': {'id': 'TVTX-RE021-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sparsentan', 'description': 'Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.', 'interventionNames': ['Drug: Sparsentan']}], 'interventions': [{'name': 'Sparsentan', 'type': 'DRUG', 'otherNames': ['Filspari', 'RE-021'], 'description': 'Target dose of 400 mg daily', 'armGroupLabels': ['sparsentan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '92844', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83202', 'city': 'Chubbuck', 'state': 'Idaho', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 42.92075, 'lon': -112.46609}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60805', 'city': 'Evergreen Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 41.72059, 'lon': -87.70172}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40205', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '71101', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '12065', 'city': 'Clifton Park', 'state': 'New York', 'country': 'United States', 'facility': 'Travere Investigation Site', 'geoPoint': {'lat': 42.86563, 'lon': -73.77095}}, {'zip': '11365', 'city': 'Fresh Meadows', 'state': 'New York', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 40.73482, 'lon': -73.79347}}, {'zip': '10013', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28546', 'city': 'Jacksonville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 34.75405, 'lon': -77.43024}}, {'zip': '28562', 'city': 'New Bern', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 35.10849, 'lon': -77.04411}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29203', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Kowloon', 'country': 'Hong Kong', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}, {'city': 'Shatin', 'country': 'Hong Kong', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'city': 'Sheung Wan', 'country': 'Hong Kong', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 22.28383, 'lon': 114.1496}}, {'city': 'Tsuen Wan', 'country': 'Hong Kong', 'facility': 'Travere Investigational Site', 'geoPoint': {'lat': 22.37137, 'lon': 114.11329}}], 'overallOfficials': [{'name': 'Radko Komers, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Travere Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'url': 'http://datarequest@travere.com', 'timeFrame': 'Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication', 'ipdSharing': 'YES', 'description': 'Requests for clinical trial data, including language stating its intended use, should be directed to datarequest@travere.com. If approved, the requested information will be provided to the requestor after signing a data access agreement. Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication. Travere reserves the right to decline or recommend modifications to a request if it does not comply with the data sharing policy or if it is determined that the request is made by a biased source.', 'accessCriteria': 'Requires submission and approval of intended use and a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Travere Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}