Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT05136456
Status:
UNKNOWN
Last Update Posted:
2023-09-05
First Post:
2021-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-03-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-31', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects achieving complete or partial remission at week 24', 'timeFrame': '24 Weeks', 'description': 'Proportion of subjects achieving complete or partial remission at week 24'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Membranous Nephropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.', 'detailedDescription': 'This study is a phase II study to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of primary membranous nephropathy based on renal biopsy before or during screening\n2. Have not received any previous immunosuppressive therapy for primary membranous nephropathy or relapse after the treatment has achieved complete or partial remission (comprehensive judgment and recording by the investigator)\n3. PLA2R-Ab titer ≥20RU/mL at screening\n4. 24-hour urinary protein ≥ 3.5g/d at screening\n5. Have eGFR ≥ 60 mL/min/1.73 m2 (based on CKD-EPI formula) at screening\n\nExclusion Criteria:\n\n1. Any clue for coexist of secondary membranous nephropathy from medical records, laboratory tests or kidney biopsy\n2. Existence of clinically significant infection within 1 month before screening,\n3. Severe or not well controlled other complications\n4. Abnormal in white blood cell count, neutrophil count, lymphocyte count or platelet count at screening, which were considered unfit for participating judged by investigators\n5. ALT \\> 2 times ULN and/or AST \\> 2 times ULN and/or bilirubin \\>2 times ULN at screening\n6. Subject has evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis\n7. Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody at screening;'}, 'identificationModule': {'nctId': 'NCT05136456', 'briefTitle': 'Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Reistone Biopharma Company Limited'}, 'officialTitle': 'A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR1459 Tablets in the Treatment of Primary Membranous Nephropathy (PMN)', 'orgStudyIdInfo': {'id': 'RSB20926'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SHR1459 Low Dose', 'description': 'Drug: SHR1459 SHR1459 oral 24weeks', 'interventionNames': ['Drug: SHR1459 Low Dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SHR1459 High Dose', 'description': 'Drug: SHR0302 SHR1459 oral 24 weeks', 'interventionNames': ['Drug: SHR1459 High Dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug: Placebo Placebo oral 24 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SHR1459 Low Dose', 'type': 'DRUG', 'description': 'SHR1459 oral tablets taken once daily (QD) for 24weeks', 'armGroupLabels': ['SHR1459 Low Dose']}, {'name': 'SHR1459 High Dose', 'type': 'DRUG', 'description': 'SHR1459 oral tablets taken once daily (QD) for 24 weeks', 'armGroupLabels': ['SHR1459 High Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo oral tablets taken once daily (QD) for 24 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Zhongshan Hospital Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': "The People's Hospital of Guangxi Zhuang Autonomous Region", 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Xiangya Hospital Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': "Jiangsu Province People's Hospital", 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda Hospital affiliated to Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Yangzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "Subei People's Hospital of Jiangsu province", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'The First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The Second Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Baotou', 'state': 'Nei Monggol', 'country': 'China', 'facility': 'The First Affiliated Hospital of Baotou Medical College', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Zhejiang Provincial People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Renji Hospital Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Ruijin Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Tongji Hospital of Tongji University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reistone Biopharma Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}