Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-01-02 @ 9:51 AM
Study NCT ID:
NCT05125068
Status:
TERMINATED
Last Update Posted:
2024-03-26
First Post:
2021-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-19', 'releaseDate': '2024-05-17'}], 'estimatedResultsFirstSubmitDate': '2024-05-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}, {'id': 'D011507', 'term': 'Proteinuria'}], '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'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'An administrative decision was made to terminate the AT-1501-N205 study. This voluntary business-related decision was not related to the safety of tegoprubart (AT-1501). Available safety data demonstrated tegoprubart to be safe and well tolerated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-25', 'studyFirstSubmitDate': '2021-11-08', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory- Change in baseline serum biomarkers', 'timeFrame': 'Through study completion, an average of 100 weeks', 'description': 'The change in serum biomarkers from baseline to completion of study'}], 'primaryOutcomes': [{'measure': 'Efficacy - change in participants UPCR', 'timeFrame': 'Up to 24 weeks', 'description': 'The change in 24-hour urine protein to creatinine ratio (UPCR) from baseline to 24 weeks'}, {'measure': 'Safety- Number of participants with treatment related adverse events', 'timeFrame': 'Through study completion, an average of 100 weeks', 'description': 'Incidence of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs of special interest (AEoSI)'}], 'secondaryOutcomes': [{'measure': 'Change in eGFR slope', 'timeFrame': 'Baseline- 96 weeks', 'description': 'The change in eGFR slope from baseline to 96 weeks'}, {'measure': 'Change in urine protein excretion (mg/mg)', 'timeFrame': 'Up to 96 weeks', 'description': 'The change in urine protein excretion over time'}, {'measure': 'Development of Anti drug Antibodies (ADAs)', 'timeFrame': 'Up to 96 weeks', 'description': 'The percentage of participants who develop ADAs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IgA Nephropathy', 'IgAN', 'AT-1501', 'CD40L', 'Monoclonal antibody', 'Proteinuria', 'eGFR', 'UPCR'], 'conditions': ['IgA Nephropathy', 'IgAN']}, 'descriptionModule': {'briefSummary': 'This is a phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening.', 'detailedDescription': 'Phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of Screening. Up to 42 eligible patients will receive one of 2 doses of AT-1501. All patients are scheduled to receive AT-1501 by intravenous infusion every 3 weeks for approximately 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age\n2. Biopsy proven IgAN\n3. Urine protein ≥ 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB)\n4. eGFR ≥ 45 mL/min per 1.73 m2 or eGFR \\< 45 mL/min per 1.73 m2 and ≥ 30 mL/min per 1.73 m2 with a kidney biopsy within 2 years of Screening showing \\< 50% tubulointerstitial fibrosis\n5. Agree to comply with contraception requirements during and for 90 days after study completion.\n\nExclusion Criteria:\n\n1. Any secondary IgAN as defined by the investigator\n2. Patients who have undergone a kidney transplant\n3. Any history of kidney disease other than IgAN\n4. Any history of diabetes (Type 1 or Type 2)\n5. Seated blood pressure \\> 140 mmHg (systolic) or \\> 90 mmHg (diastolic) at the Screening Visit. Patients must be on a stable dose and regimen of an ACE inhibitor or ARB for at least 90 days\n6. Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT05125068', 'briefTitle': 'Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eledon Pharmaceuticals'}, 'officialTitle': 'A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy', 'orgStudyIdInfo': {'id': 'AT-1501-N205'}, 'secondaryIdInfos': [{'id': '2021-004795-34', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1269-7356', 'type': 'OTHER', 'domain': 'Universal Trial Number (UTN)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'AT-1501 10mg/kg Arm A will receive 10 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions.', 'interventionNames': ['Drug: AT-1501']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'AT-1501 5mg/kg Arm B will receive 5 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions', 'interventionNames': ['Drug: AT-1501']}], 'interventions': [{'name': 'AT-1501', 'type': 'DRUG', 'description': 'AT-1501 monoclonal antibody targeting CD40L given as an IV infusion', 'armGroupLabels': ['Arm A', 'Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NSW 2170', 'city': 'Liverpool', 'state': 'South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Centre', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'city': 'St Albans', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Western Health', 'geoPoint': {'lat': -37.74496, 'lon': 144.80049}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'University Hospital Centre Sisters of Charity', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'University Hospital Dubrava Zagreb', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '59100', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur WP', 'country': 'Malaysia', 'facility': 'University Malaya Medical Centre (UMMC)', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '25100', 'city': 'Kuantan', 'state': 'Pahang', 'country': 'Malaysia', 'facility': 'Hospital Tengku Ampuan Afzan (HTAA)', 'geoPoint': {'lat': 3.8077, 'lon': 103.326}}, {'city': 'Kota Kinabalu', 'state': 'Sabah', 'country': 'Malaysia', 'facility': 'Hospital Queen Elizabeth', 'geoPoint': {'lat': 5.9749, 'lon': 116.0724}}, {'zip': '43000', 'city': 'Kajang', 'state': 'Selangor', 'country': 'Malaysia', 'facility': 'Hospital Kajang', 'geoPoint': {'lat': 2.99424, 'lon': 101.78875}}, {'zip': '43000', 'city': 'Kajang', 'state': 'Selangor', 'country': 'Malaysia', 'facility': 'Hospital Serdang', 'geoPoint': {'lat': 2.99424, 'lon': 101.78875}}, {'zip': '3204', 'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Waikato Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': '4120', 'city': 'Hastings', 'country': 'New Zealand', 'facility': "Hawke's Bay Hospital", 'geoPoint': {'lat': -39.6381, 'lon': 176.84918}}, {'city': 'Sampaloc', 'state': 'Manila', 'country': 'Philippines', 'facility': 'University of Santo Tomas Hospital', 'geoPoint': {'lat': 14.5402, 'lon': 121.3602}}, {'city': 'Bialystok', 'country': 'Poland', 'facility': 'Medical University of Bialystok UI', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Specjalistyczne Centrum Medyczne, SCM Spółka', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Sagunto', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital de Sagunto', 'geoPoint': {'lat': 39.68333, 'lon': -0.26667}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen de la Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '01000', 'city': 'Colombo', 'country': 'Sri Lanka', 'facility': 'National Hospital of Sri Lanka', 'geoPoint': {'lat': 6.93548, 'lon': 79.84868}}, {'zip': '10250', 'city': 'Nugegoda', 'country': 'Sri Lanka', 'facility': 'Sri Jayawardanepura General Hospital', 'geoPoint': {'lat': 6.8735, 'lon': 79.8899}}, {'city': 'Dusit', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Prince of Songkla University', 'geoPoint': {'lat': 13.7775, 'lon': 100.51977}}, {'zip': '10330', 'city': 'Pathum Wan', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn University', 'geoPoint': {'lat': 13.73649, 'lon': 100.5239}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Phramongkutklao Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'city': 'Camberwell', 'country': 'United Kingdom', 'facility': 'Kings College Hospital', 'geoPoint': {'lat': 51.4739, 'lon': -0.09381}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eledon Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-05-17', 'type': 'RELEASE'}, {'date': '2024-09-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Eledon Pharmaceuticals'}}}}