Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT05782933
Status:
UNKNOWN
Last Update Posted:
2023-03-24
First Post:
2022-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Rituximab Combined With Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015433', 'term': 'Glomerulonephritis, Membranous'}], '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': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2022-12-18', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'remission of nehprotic syndrome', 'timeFrame': '12 months', 'description': 'The primary clinical outcome was a composite outcome with complete remission or partial remission of nehprotic syndrome at 12 months. Complete remission was defined as a reduction of proteinuria to ≤ 0.3 g/24 h plus stable kidney function (eGFR ≥45 mL/min per 1.73 m2). Partial remission was defined as a reduction of proteinuria of ≥ 50% from baseline, and \\<3.5 g/24 h plus stable renal function (eGFR ≥45 mL/min per 1.73 m2).'}], 'secondaryOutcomes': [{'measure': 'Complete remission of nehprotic syndrome', 'timeFrame': '12 months', 'description': 'Complete remission was defined as a reduction of proteinuria to ≤ 0.3 g/24 h plus stable kidney function (eGFR ≥45 mL/min per 1.73 m2).'}, {'measure': 'adverse events', 'timeFrame': '12 months', 'description': 'The prevalence of adverse events including infections, hyperglycemia etc will be recored.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Membranous Nephropathy']}, 'descriptionModule': {'briefSummary': 'Idiopathic membranous nephropathy (IMN) is one of the common types of primary glomerular diseases and the most common cause of nephrotic syndrome in adults.\n\nPoticelli regimen is the classic treatment, but cyclophosphamide has many toxic side effects. The period of glucocorticoid therapy is relatively long, and the adverse reactions caused by glucocorticoid therapy cannot be ignored. For patients who are unwilling to receive glucocorticoids and cyclophosphanide or who have treatment contraindications, cyclosporine can be used, mainly cyclosporine and tacrolimus, with the rapid overall effect but a high short-term relapse rate. In recent years, rituximab therapy has become a first-line treatment, with a high remission rate, and few side effects, but expensive. In terms of efficacy alone, the above regimen did not exceed Poticelli regimen. However, the toxic side effects of rituximab, cyclosporine may be lower than that of Poticelli regimen. Based on the preliminary experiment, this study explored a new treatment plan: low-dose rituximab combined with cyclosporine in the treatment of IMN, the efficacy is not inferior to Poticelli regimen, but the side effects are significantly reduced. The result will provide a good choice for IMN patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 18-70 years; serum albumin level \\<30 g/L;\n2. estimated glomerular filtration rate (eGFR according to the CKD-EPI formula) ≥60 mL/min per 1.73 m2;\n3. patients with a moderate risk of IMN and decline \\<50% in proteinuria despite blockade of the renin-angiotensin system 3 months before randomization;\n4. patients at high risk or very high risk of IMN.\n\nExclusion Criteria:\n\n1. secondary causes of MN;\n2. being pregnant or breastfeeding;\n3. uncontrollable active infectious disease;\n4. immunosuppressive treatment in the preceding 3 months.'}, 'identificationModule': {'nctId': 'NCT05782933', 'briefTitle': 'Efficacy of Rituximab Combined With Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Efficacy and Safety of Low Dose Rituximab Combined With Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy', 'orgStudyIdInfo': {'id': '2022-P2-250-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab', 'description': 'Patients received rituximab 100 and 500 mg of intravenous medication on days 1 and 2, respectively. If proteinuria was reduced from baseline by no more than 25% at 3 months, cyclosporine was administered. In addition, CD19+ B-cell count was monitored every 3 months, and another rituximab 100 and 500 mg will be administered if CD19+ B-cell count \\>5 cells/mL.', 'interventionNames': ['Drug: Rituximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Modified Ponticelli regimen', 'description': 'Patients received corticosteroids at months 1, 3, and 5 (methylprednisolone 0.5 g at days 1, 2, and 3, then prednisone 0.5 mg/kg/d from day-4 to day-30). At months 2, 4, and 6, patients received cyclophosphamide adjusted for age and renal function (1.0-2.0 mg/kg/day for 30 days, maximum dose 100 mg/d).', 'interventionNames': ['Drug: Modified Ponticelli regimen']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'description': 'Rituximab combined with or without cyclosporine', 'armGroupLabels': ['Rituximab']}, {'name': 'Modified Ponticelli regimen', 'type': 'DRUG', 'description': 'Corticosteroid and cyclophosphamide', 'armGroupLabels': ['Modified Ponticelli regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zongli Diao, M.D.', 'role': 'CONTACT', 'email': 'diaozl@ccmu.edu.dn', 'phone': '+861063138679'}], 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Wenhu Liu', 'investigatorFullName': 'Wenhu Liu', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}