[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576180":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":38,"responsibleParty":56,"collaborators":23,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":23,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":23,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":23,"overallStatus":41,"whyStopped":23,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Huashan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Obinutuzumab","EXPERIMENTAL","Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26.",[13],"Drug: Obinutuzumab",{"label":15,"type":6,"description":15,"interventionNames":16},"Comparator",[17],"Drug: CTX combined with Glucocorticoids",[19,24],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Drug: Obinutuzumab Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26.",[9],null,{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"CTX combined with Glucocorticoids","Drug: Glucocorticoids Methylprednisolone 500 mg iv will be given for 3 consecutive days at the start of month 1,3,5 and followed by prednisone 0.5mg\u002Fkg\u002Fd (max 40mg\u002Fd) for 27 days.\n\nDrug: CTX\n\nOral cyclophosphamide will be given for 30 days in month 2, 4, 6.",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},"Chuanming Hao C Chuanming Hao","CONTACT","+86-13501639098","chuanminghao@fudan.edu.cn",{"name":35,"role":31,"phone":36,"phoneExt":23,"email":37},"Qionghong Xie Q Qionghong Xie","+86-18121186869","qionghongxie@fudan.edu.cn",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Huashan Hospital, Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200040","China","CN",{"type":48,"coordinates":49},"Point",[50,51],121.45806,31.22222,{"lat":51,"lon":50},[54],{"name":35,"role":31,"phone":55,"phoneExt":23,"email":37},"18121186869",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Chuanming Hao","Professor","100576180","phase-3-obinotuzumab-versus-cyclophosphamide--glucocorticoids-in-primary-membranous-nephropathyblossom-study-100576180",false,"NCT06781944","OBINOTUZUMAB Versus Cyclophosphamide + Glucocorticoids in Primary Membranous Nephropathy(Blossom Study)","A Multicenter, Open- Label, Randomized, Clinical Trial to Investigate the Efficacy and Safety of OBINOTUZUMAB Versus Cyclophosphamide Combined With Glucocorticoids in Patients With Primary Membranous Nephropathy (Blossom Study)","Inclusion Criteria:\n\n* Aged 18～75 years (including 18 and 75)old at the time of signing Informed Consent Form\n* pMN patients diagnosed according to renal biopsy (original biopsy needs to include light, immunofluorescence, and electron microscopy) within 5 years or serum anti-PLA2R antibody (≥14 RU\u002Fml )\n* 24-hour UPCR ≥ 4 g\u002Fg and serum albumin (sALB) \\\u003C 30 g\u002FL,despite being treated with ACEi and\u002For ARB for ≥ 6 months prior to screening, or 24-hour UPCR ≥ 5 g\u002Fg and sALB \\\u003C 30 g\u002FL , despite being treated with ACEi and\u002For ARB for ≥ 3 months prior to screening; or 24-hour UPCR ≥ 8 g\u002Fg and sALB \\\u003C 25 g\u002FL, despite being treated with ACEi and\u002For ARB for ≥ 1 month prior to screening,.\n* eGFR ≥40 mL\u002Fmin\u002F1.73m2 (CKD-EPI), a renal biopsy is required to exclude renal damage due to other co-morbidities if eGFR \\\u003C60mL\u002Fmin\u002F1.73 m2.\n* Ability to comply with the study protocol, in the investigator's judgment\n\nExclusion Criteria:\n\n* Patients with a secondary cause of MN (e.g. hepatitis B, systemic lupus erythematosus, medications, malignancies)\n* Type 1 or 2 diabetes mellitus\n* eGFR \\\u003C40 mL\u002Fmin\u002F1.73m2 (CKD-EPI) or dialysis or kidney transplantation\n* Evidence of 50% reduction in proteinuria or serum anti-PLA2R antibody within 6 months prior to screening","ALL","18 Years","75 Years",{"count":71,"type":72},144,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","This is a randomized, parallel group, active-controlled, open-label, Phase III study comparing the efficacy and safety of obinutuzumab versus cyclophosphamide combined with glucocorticoids in patients with primary membranous nephropathy (pMN). Approximately 144 patients with pMN who have been diagnosed by biopsy or serum anti-PLA2R antibody will be enrolled.\n\nIntervention: Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26 Comparator: Cyclical cyclophosphamide and glucocorticoids Methylprednisolone 500 mg iv will be given for 3 consecutive days at the start of month 1,3,5 and followed by prednisone 0.5mg\u002Fkg\u002Fd (max 40 mg\u002Fd) for 27 days.\n\nOral cyclophosphamide will be given for 30 days in month 2, 4, 6.",[78],"Primary Membranous Nephropathy","2026-01-16",{"date":81,"type":82},"2026-01-21","ACTUAL",{"date":84,"type":82},"2024-10-23",{"date":86,"type":72},"2028-05-31",{"name":5,"class":6},1]