[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659102":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":25,"studyPopulation":18,"armGroups":26,"interventions":38,"overallOfficials":18,"centralContacts":47,"locations":53,"responsibleParty":69,"collaborators":73,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":18,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":18,"studyType":94,"phases":95,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":55,"whyStopped":18,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Remission Status","the proportion of subjects to reach the composite of maintaining complete remission or partial remission at 3 months after randomization","At 3 months after randomization",[14],{"measure":15,"description":16,"timeFrame":17},"Remission at 6 months and 12 months","The proportions of patients achieving complete remission or partial remission at 6 and 12 months of treatment.","From enrollment to the end of follow-up at 12 months",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE","Primary membranous nephropathy (PMN) is one of the most common causes of nephrotic syndrome among Chinese adults. For patients with high-grade proteinuria , immunosuppressive therapy is needed. B cell-depleting agent Rituximab is a recommended treatment Regimen in maintaining remission but the response to Rituximab is relatively slow. Calcineurin inhibitors lead to earlier reductions in proteinuria but presenting higher relapse rates in the long follow-up period.Combination therapy may provide both earlier proteinuria remission and durable effect. This is a multi-center, randomized, open-label study conducted in adult patients with biopsy-proven PMN. The main purpose of this study is to determine whether Rituximab combined with Cyclosporine is superior to Rituximab monotherapy in inducing remission of proteinuria in patients with PMN.",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"combination therapy","ACTIVE_COMPARATOR","Rituximab combined with cyclosporine",[32],"Drug: Rituximab combined with cyclosporine",{"label":34,"type":29,"description":35,"interventionNames":36},"monotherapy","Rituximab",[37],"Drug: rituximab",[39,43],{"type":40,"name":30,"description":41,"armGroupLabels":42,"otherNames":18},"DRUG","The first cycle of rituximab was given at a dose of 1000 mg i.v. on day 1 and day 15.Patients were retreated with rituximab (1000mg ) when CD20 B-cell count was more than 5 cells\u002Fml.Oral cyclosporine will be started at 3 mg\u002Fkg\u002Fday and continued for 6 months, followed by a 2-month tapering period.",[28],{"type":40,"name":44,"description":45,"armGroupLabels":46,"otherNames":18},"rituximab","The first cycle of rituximab was given at a dose of 1000 mg i.v. on day 1 and day 15.Patients were retreated with rituximab (1000mg ) when CD20 B-cell count was more than 5 cells\u002Fml.",[34],[48],{"name":49,"role":50,"phone":51,"phoneExt":18,"email":52},"Fang Wang, Doctor","CONTACT","01083572388","wangfang@bjmu.edu.cn",[54],{"facility":5,"status":55,"city":56,"state":18,"zip":18,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Beijing","China","CN",{"type":60,"coordinates":61},"Point",[62,63],116.39723,39.9075,{"lat":63,"lon":62},[66],{"name":67,"role":50,"phone":68,"phoneExt":18,"email":52},"Fang Wang","86-10-83572388",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Zhao CUI","MD",[74,77,79],{"name":75,"class":76},"China Rehabilitation Research Center","OTHER_GOV",{"name":78,"class":6},"Fu Xing Hospital, Capital Medical University",{"name":80,"class":6},"People's Hospital of Beijing Daxing District","100659102","phase-2-combination-of-rituximab-and-cyclosporine-in-the-treatment-of-primary-membranous-nephropathy-100659102",false,"NCT07861204","Combination of Rituximab and Cyclosporine in the Treatment of Primary Membranous Nephropathy","Efficacy and Safety of Rituximab Combined With Cyclosporine for Primary Membranous Nephropathy","Inclusion Criteria:\n\n1. Age 18-80 years.\n2. Primary membranous nephropathy confirmed by renal biopsy.\n3. 24-hour urinary protein quantification \\> 5.0 g\u002F24h and serum albumin \\\u003C 30 g\u002FL after at least 3 months of treatment with RAAS blockers.\n4. eGFR ≥ 40 mL\u002Fmin\u002F1.73 m².\n5. Well-controlled blood pressure (≤140\u002F90 mmHg) in the recent 3 months.\n6. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Secondary causes of membranous nephropathy, such as that secondary to systemic lupus erythematosus, malignant tumors, hepatitis B virus infection, heavy metal poisoning;\n2. Coexistence of other types of kidney diseases;\n3. Use of rituximab within the past 12 months;\n4. Use of corticosteroids, cyclophosphamide, cyclosporine, mycophenolate mofetil, or leflunomide within the past 3 months;\n5. Active infection: active tuberculosis, HBsAg positivity or HBV-DNA indicating viral replication, positive HCV antibody, HIV infection;\n6. New-onset cardiovascular or cerebrovascular diseases within the past 3\n7. Severe liver disease: AST and ALT \\> 3 times range upper limit ;\n8. Uncontrolled severe hypertension;\n9. Newly diagnosed or recurrent malignant tumors within the past 5 years;\n10. Coexistent autoimmune diseases;\n11. Pregnancy, lactation, or recent plans for pregnancy;\n12. Life expectancy less than 12 months;\n13. Participation in other clinical trials within the past 3 months;\n14. Unwillingness to sign the informed consent form;\n15. Any other condition deemed unsuitable for the study by the investigator.","ALL","18 Years","80 Years",{"count":92,"type":93},90,"ESTIMATED","INTERVENTIONAL",[96,97],"PHASE2","PHASE3","High-grade proteinuria is one of the key determinants of adverse renal prognosis in patients with primary membranous nephropathy (PMN).The main purpose of this study is to determine whether Rituximab combined with Cyclosporine is superior to Rituximab monotherapy in inducing remission of proteinuria in patients with PMN.",[100],"Membranous Nephropathy",[102,35,103],"membranous nephropathy","Cyclosporine","2026-10-02",{"date":106,"type":107},"2026-10-06","ACTUAL",{"date":109,"type":107},"2026-01-21",{"date":111,"type":93},"2027-12-30",{"name":5,"class":6},1]