Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT05847920
Status:
TERMINATED
Last Update Posted:
2025-03-05
First Post:
2023-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary 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'}]}}, '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': 53}}, 'statusModule': {'whyStopped': 'Based on the adjustment of the R \\& D strategy, the sponsor decides to terminate the research.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-02', 'studyFirstSubmitDate': '2023-04-27', 'studyFirstSubmitQcDate': '2023-04-27', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks.', 'timeFrame': '12 weeks'}, {'measure': 'Part 2: change from baseline in UPCR at 24weeks.', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'change from baseline in 24 hours urinary protein at 12 weeks (part 1)', 'timeFrame': '12 weeks'}, {'measure': 'change from baseline in 24 hours urinary protein at 24 weeks (part 2)', 'timeFrame': '24 weeks'}, {'measure': 'change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks（Part 1）', 'timeFrame': '12 weeks'}, {'measure': 'change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks（Part 2）.', 'timeFrame': '24 weeks'}, {'measure': 'change from baseline in glomerular filtration rate (eGFR) at 12weeks and 24weeks （Part 1）.', 'timeFrame': '12, 24 weeks'}, {'measure': 'change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks （Part 2）.', 'timeFrame': '24, 36 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary 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': 'The study is being conducted to evaluate the efficacy, and safety of SHR - 2010 injection in patients with primary IgA nephropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent\n2. Renal biopsy confirmed primary IgA nephropathy\n3. 24 hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g\n4. eGFR≥30 mL/min/ 1.73m2\n5. 40kg≤ Weight ≤100kg\n6. Has been treated with optimized supportive treatment. (ACEI or ARB to maximum recommended dose or maximum tolerated dose).\n\nExclusion Criteria:\n\n1. systemic disease which may cause secondary IgA deposition in the mesangial region\n2. Specific type of IgA nephropathy\n3. History of severe opportunistic infection\n4. A history of chronic or recurrent infection within 1 year prior to screening\n5. History of active digestive system within one year\n6. Have a malignant tumor or a history of malignant tumor\n7. Subjects who have received organ transplants\n8. Associated with other serious or poorly controlled systemic diseases\n9. Hepatitis, syphilis, human immunodeficiency virus (HIV) infection\n10. Received systemic immunosuppressive drugs other than glucocorticoids 8 weeks before screening or during run-in period.\n11. Received any systemic glucocorticoid 8 weeks before screening or during run-in period'}, 'identificationModule': {'nctId': 'NCT05847920', 'briefTitle': 'Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong Hengrui Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Phase II Seamless Design, Randomized, Double-blind, Placebo-controlled, Dose-exploration Study Evaluate the Efficacy and Safety of SHR-2010 Injection in Patients With Primary IgA Nephropathy', 'orgStudyIdInfo': {'id': 'SHR-2010-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-2010 Injection', 'interventionNames': ['Drug: SHR-2010 Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SHR-2010 Injection', 'type': 'DRUG', 'description': 'SHR-2010 Injection', 'armGroupLabels': ['SHR-2010 Injection']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'General Hospital of Eastern Theater Command', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Hengrui Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}