Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis
Starting soon · Phase 2
Conditions studied: ANCA-Associated Glomerulonephritis (AAGN), ANCA-Associated Vasculitis (AAV)
In brief
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).
Key facts
- Study ID
- NCT07746180
- Run by
- Chinese PLA General Hospital
- People needed
- 20
- Starts
- 2026-07-31
- Expected to finish
- 2029-03-30
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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