Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis | NCT07746180

NCT07746180

Overview

NCT ID: NCT07746180
Lead Sponsor: Chinese PLA General HospitalOTHER
Official Title: Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis: A Prospective Exploratory Study
Brief 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).
Conditions: ANCA-Associated Glomerulonephritis (AAGN)
ANCA-Associated Vasculitis (AAV)
Interventions: Obinutuzumab beta

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

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