[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563347":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":44,"locations":50,"responsibleParty":64,"collaborators":35,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":35,"enrollmentInfo":77,"targetDuration":35,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":35,"overallStatus":86,"whyStopped":35,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Renmin Hospital of Wuhan University","OTHER",[8,15,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","ACTIVE_COMPARATOR","After completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Patients who have achieved complete or partial remission are then randomly assigned to either Group A or Group B at a 1:1 ratio.\n\nMedication regimen of Group A： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Cyclophosphamide injection：an intravenous injection of 0.4 g is administered twice a month.",[13,14],"Drug: Prednisone","Drug: Cyclophosphamide",{"label":16,"type":17,"description":18,"interventionNames":19},"Group B","EXPERIMENTAL","Medication regimen of Group B： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Telitacicept injection：an intravenous injection of 0.4 g is administered twice a month.",[20,13],"Drug: Telitacicept",{"label":22,"type":10,"description":23,"interventionNames":24},"Group C","After completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Non-responders are randomly assigned to either Group C or Group D at a 1:1 ratio.\n\nMedication regimen of Group C： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Cyclophosphamide injection：an intravenous injection of 0.4 g is administered twice a month.",[13,14],{"label":26,"type":17,"description":27,"interventionNames":28},"Group D","Medication regimen of Group D： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Telitacicept injection：an intravenous injection of 0.4 g is administered twice a month.",[20,13,14],[30,36,40],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Telitacicept","Subcutaneous injection of 160 mg is administered once a week.",[16,26],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Prednisone","Induction therapy period (3 months)：Eligible subjects receive induction treatment with Methylprednisone 0.5 g i. v. for 3 consecutive day and followed by orally administration of prednisone at an initial dose of 0.8 mg\u002Fkg\u002Fday, tapered gradually after 2 months (reduced by 5 mg every 2 weeks) Grouped treatment period (6 months): The maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation.",[9,16,22,26],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Cyclophosphamide","An intravenous injection of 0.4 g is administered twice a month.",[9,22,26],[45],{"name":46,"role":47,"phone":48,"phoneExt":35,"email":49},"Huiming Wang, PhD","CONTACT","+86 18971563100","rm000301@whu.edu.cn",[51],{"facility":52,"status":35,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":35},"Renmin Hospital of Wuhan university","Wuhan","Hubei China","430075","China","CN",{"type":59,"coordinates":60},"Point",[61,62],114.26667,30.58333,{"lat":62,"lon":61},{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","Huiming Wang","Director, Department of Nephrology","100563347","phase-2-the-efficacy-and-safety-of-treatment-with-telitacicept-in-primary-membranous-nephropathy-100563347",false,"NCT06614985","The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy","TEST-T-PMN","Inclusion Criteria:\n\n1. Patients must have a confirmed diagnosis of primary membranous nephropathy through renal biopsy to be eligible for inclusion in the study.\n2. Adult patients aged 18 years or older of any gender are eligible for inclusion in the study.\n3. Patients who meet the diagnostic criteria for nephrotic syndrome, which includes quantitative urine protein levels greater than 3.5 g\u002F24 h and serum albumin levels less than 30 g\u002FL, are eligible for inclusion in the study.\n4. Patients who meet the high-risk criteria for progression of membranous nephropathy based on the KDIGO (Kidney Disease: Improving Global Outcomes) guidelines are eligible for inclusion in the study. High-risk criteria include eGFR less than 60 mL\u002Fmin\u002F1.73 m2 and\u002For urine protein excretion greater than 8 g\u002Fday for at least 6 months, or normal eGFR with urine protein excretion greater than 3.5 g\u002Fday and urine protein reduction less than 50% after 6 months of ACEI\u002FARB treatment, with any of the following criteria: serum albumin less than 25 g\u002FL, anti-PLA2R antibody greater than 50 RU\u002FmL, urine α1-microglobulin greater than 40 μg\u002Fmin, urine IgG1 greater than 1 μg\u002Fmin, urine β2-microglobulin greater than 250 mg\u002Fday, and SI greater than 0.2.\n5. Participants are required to consent to use effective contraception methods with their partners throughout the entire duration of the study. Participants must have a thorough understanding of the nature, significance, potential benefits, inconveniences, and potential risks of the study and voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n1. Secondary membranous nephropathy patients (caused by autoimmune or infectious diseases, tumors, etc.);\n2. Patients with HIV infection, viral hepatitis, active liver disease (with ALT\u002FAST\u002Fbilirubin levels exceeding 3 times the upper limit of normal), or other severe infections;\n3. Patients with a rapid decline in eGFR (\\>15 mL\u002Fmin) during the screening period are excluded;\n4. Patients who have undergone kidney transplantation or other organ transplantation;\n5. Patients with a known allergy or hypersensitivity to the active ingredient of the investigational drug or any of the listed excipients;\n6. Patients with acute or critical cardiovascular or cerebrovascular diseases;\n7. Patients with immunodeficiency, hypoalbuminemia (IgG \\\u003C 400 mg\u002Fdl), or IgA deficiency (IgA \\\u003C 10 mg\u002FdL);\n8. Pregnant or lactating women;\n9. Patients diagnosed with malignant tumors within the past 5 years;\n10. Laboratory findings of severe abnormalities (Hb \\\u003C 80 g\u002FL, PLT \\\u003C 50,000\u002Fmm3, neutrophil count \\\u003C 1,000\u002Fmm3, etc.);\n11. Patients who have used steroids or immunosuppressive agents (including but not limited to corticosteroids, adrenocorticotropic hormones, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine, biologic agents such as rituximab, etc.), cyclophosphamide, bortezomib, dexamethasone, Chinese medicines or preparations containing Tripterygium wilfordii, intravenous immunoglobulin, plasma exchange, leukapheresis, live vaccines, or other investigational drugs, etc., within 3 months prior to screening;\n12. Patients with other diseases or conditions that, in the opinion of the investigator, would render the patient unsuitable for participation in this study;","ALL","18 Years",{"count":78,"type":79},172,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","This is a multiple-center, prospective, open-label, positive drug controlled, randomized, clinical study to evaluate the safety and efficacy of Telitacicept in the treatment of primary membranous nephropathy.",[85],"Primary Membranous Nephropathy","NOT_YET_RECRUITING","2024-09-23",{"date":89,"type":90},"2024-09-26","ACTUAL",{"date":92,"type":79},"2024-10-20",{"date":94,"type":79},"2027-10-01",{"name":5,"class":6},1]