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NCT07746180
Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis
Conditions: ANCA-Associated Glomerulonephritis (AAGN), ANCA-Associated Vasculitis (AAV)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 20
Sponsor: Chinese PLA General Hospital
Summary
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).
Eligibility Criteria
Inclusion Criteria:
* New diagnosis of ANCA-associated vasculitis (Granulomatosis with polyangiitis \[GPA\] or Microscopic polyangiitis \[MPA\]) according to the Chapel Hill Consensus Conference definitions.
* Positive for PR3-ANCA or MPO-ANCA.
* Active renal involvement indicated by recent renal biopsy (pauci-immune necrotizing and/or crescentic glomerulonephritis) OR active urine sediment characterized by glomerular hematuria and proteinuria.
* Provided signed informed consent.
Exclusion Criteria:
* Prior treatment with targeted B-cell therapies (e.g., Rituximab) or standard cyclophosphamide, azathioprine, or mycophenolate mofetil for AAV.
* Current requirement for dialysis, or history of dialysis.
* Presence of life-threatening acute vasculitis manifestations other than renal involvement (e.g., diffuse alveolar hemorrhage, respiratory failure, bowel perforation, cerebral vasculitis).
* History of malignancy within the past 5 years.
* Coexisting multisystem autoimmune diseases (e.g., systemic lupus erythematosus, anti-GBM disease).
* Active severe infections, active tuberculosis, or chronic viral infections (HBV with positive HBsAg or HBV-DNA, active HCV, HIV).
* Pregnant or lactating women.
Source: ClinicalTrials.gov (NCT07746180). StuddyBuddy aggregates publicly available trial information.