Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT04905212
Status:
TERMINATED
Last Update Posted:
2023-12-06
First Post:
2021-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C000722462', 'term': 'telitacicept'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Decision that continuing with the study would not generate useful data', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2021-05-21', 'studyFirstSubmitQcDate': '2021-05-23', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The incidence and severity of adverse events', 'timeFrame': '27 weeks', 'description': 'Number and intensity of adverse events'}, {'measure': 'Immunogenicity endpoints', 'timeFrame': 'Week 0, 4, 8, 12, 16, 20, 24 and 27', 'description': 'Anti-drug antibody (ADA), incidence, titers and duration'}, {'measure': 'Biomaker endpoints serum concentration', 'timeFrame': 'Week 0, 4, 8, 12, 16, 20, and 24', 'description': 'BLyS serum concentration, APRIL serum concentration, and BLyS-drug complex'}, {'measure': 'Pharmacokinetic endpoints', 'timeFrame': 'Week 0, 4, 8, 12, 16, 20, 24 and 27', 'description': 'Free Telitacicept serum concentration and total Telitacicept serum concentration'}], 'primaryOutcomes': [{'measure': 'Change from baseline in 24-hour urine protein at Week 24.', 'timeFrame': 'Week 24', 'description': 'Change from baseline in urine protein over 24 hours to Week 24 will be measured'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48', 'description': 'Change from baseline in eGFR by visit'}, {'measure': 'Change from baseline in urine protein-to-creatinine ratio (UPCR) and urine albumin-to-creatinine ratio (UACR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48;', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48', 'description': 'Change from baseline in Urine protein-to-creatinine ratio (UPCR) and Urine albumin-to-creatinine ratio (UACR) by visit.'}, {'measure': 'Change from baseline in immunological parameters (IgA, IgG, IgM, C3, C4, and B lymphocytes) at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.', 'description': 'Changes from baseline in Immunoglobulins (IgA, IgG, IgM), B lymphocytes (CD19+), complements (C3, C4)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Berger Disease', "Berger's Disease", 'IGA Glomerulonephritis', 'IGA Nephropathy', 'Primary IGA Nephropathy', 'Immunoglobulin A Nephropathy Nephritis', 'IGA Type Nephropathy, IGA'], 'conditions': ['IgA 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.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.', 'detailedDescription': 'IgA nephropathy is a kidney disease in which IgA, a protein meant to defend the body against foreign invaders, accumulates in the kidneys and damages them. This study will seek to determine the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.\n\nThe study is composed of 4 parts: a screening period, a double-blind treatment period, an optional open label extension, and a follow-up period. Subjects with confirmed IgA nephropathy will be enrolled and randomized 1:1:1 to Telitacicept 160 mg, Telitacicept 240 mg, or placebo (10 per arm).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. IgA nephropathy confirmed by pathological biopsy;\n2. Male or female aged ≥ 18 years old;\n3. Average 24-hour urine total protein ≥ 0.75 g/24 h\n4. Estimated GFR (using the CKD-EPI formula) \\> 30 mL/min per 1.73 m\\^2;\n5. Stabilized AEI/ARB medications, diuretics, or other antihypertensive therapy.\n\nExclusion Criteria:\n\n1. Patients with clinically significant abnormal laboratory tests at screening;\n2. Evidence of rapid eGFR decrease \\> 15 ml/min during screening;\n3. Renal or other organ transplantation prior to, or expected during, the study;\n4. Patients with secondary IgA nephropathy;\n5. Patients with nephrotic syndrome, crescentic nephritis minimal change nephropathy with IgA deposition, or other pathological or clinical types of renal diseases that may confound the study data interpretation;\n6. Patients with history of any severe unstable cardiovascular and cerebrovascular events within 12 weeks prior to screening;\n7. Immunocompromised individuals.'}, 'identificationModule': {'nctId': 'NCT04905212', 'briefTitle': 'A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'RemeGen Co., Ltd.'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) With an Optional Open Label Extension in Subjects With IgA Nephropathy', 'orgStudyIdInfo': {'id': 'RC18G004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telitacicept 160mg', 'description': 'Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses', 'interventionNames': ['Drug: Telitacicept 160mg']}, {'type': 'EXPERIMENTAL', 'label': 'Telitacicept 240mg', 'description': 'Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses', 'interventionNames': ['Drug: Telitacicept 240mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo subcutaneous injection once weekly, and a total of 24 doses', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Telitacicept 160mg', 'type': 'DRUG', 'description': 'Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.', 'armGroupLabels': ['Telitacicept 160mg']}, {'name': 'Telitacicept 240mg', 'type': 'DRUG', 'description': 'Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.', 'armGroupLabels': ['Telitacicept 240mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Remegen Site #5', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91324', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Remegen Site #13', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91324', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Remegen Site #14', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95687', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Remegen Site #10', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94080', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Remegen Site #8', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33071', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Remegen Site #16', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Remegen Site #17', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '17033', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Remegen Site #2', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RemeGen Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}