[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650118":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":28,"locations":27,"responsibleParty":34,"collaborators":27,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":27,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":27,"enrollmentInfo":46,"targetDuration":27,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":58,"whyStopped":27,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":27},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Obinutuzumab beta + Glucocorticoid","EXPERIMENTAL","Participants receive Obinutuzumab beta intravenous infusion during induction phase, combined with oral glucocorticoids following a prespecified rapid tapering schedule aiming for complete discontinuation by Week 24.",[13,14],"Drug: Obinutuzumab beta","Drug: Glucocorticoids",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Obinutuzumab beta","Intravenous infusion of Obinutuzumab beta administered during the induction phase.",[9],[22],"MIL62",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Glucocorticoids","Oral glucocorticoid induction starting alongside Obinutuzumab beta, following a prespecified rapid tapering schedule aimed at complete discontinuation by Week 24.",[9],null,[29],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},"Zhe Feng","CONTACT","+86 010-66935462","zhezhe_4025@126.com",{"type":35,"investigatorFullName":30,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Chief Physician, Professor, Department of Nephrology, Chinese PLA General Hospital","100650118","phase-2-obinutuzumab-beta-combined-with-low-dose-glucocorticoid-in-new-onset-anca-associated-glomerulonephritis-100650118",false,"NCT07746180","Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis","Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis: A Prospective Exploratory Study","Inclusion Criteria:\n\n* New diagnosis of ANCA-associated vasculitis (Granulomatosis with polyangiitis \\[GPA\\] or Microscopic polyangiitis \\[MPA\\]) according to the Chapel Hill Consensus Conference definitions.\n* Positive for PR3-ANCA or MPO-ANCA.\n* Active renal involvement indicated by recent renal biopsy (pauci-immune necrotizing and\u002For crescentic glomerulonephritis) OR active urine sediment characterized by glomerular hematuria and proteinuria.\n* Provided signed informed consent.\n\nExclusion Criteria:\n\n* Prior treatment with targeted B-cell therapies (e.g., Rituximab) or standard cyclophosphamide, azathioprine, or mycophenolate mofetil for AAV.\n* Current requirement for dialysis, or history of dialysis.\n* Presence of life-threatening acute vasculitis manifestations other than renal involvement (e.g., diffuse alveolar hemorrhage, respiratory failure, bowel perforation, cerebral vasculitis).\n* History of malignancy within the past 5 years.\n* Coexisting multisystem autoimmune diseases (e.g., systemic lupus erythematosus, anti-GBM disease).\n* Active severe infections, active tuberculosis, or chronic viral infections (HBV with positive HBsAg or HBV-DNA, active HCV, HIV).\n* Pregnant or lactating women.","ALL","18 Years",{"count":47,"type":48},20,"ESTIMATED","INTERVENTIONAL",[51],"PHASE2","This study is an open-label, single-arm, exploratory study designed to evaluate the efficacy and safety of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in patients with new-onset ANCA-associated glomerulonephritis (AAGN).",[54,55],"ANCA-Associated Glomerulonephritis (AAGN)","ANCA-Associated Vasculitis (AAV)",[54,18,57],"Glucocorticoid","NOT_YET_RECRUITING","2026-07-30",{"date":61,"type":62},"2026-08-04","ACTUAL",{"date":64,"type":48},"2026-07-31",{"date":66,"type":48},"2029-03-30",{"name":5,"class":6}]