Obinutuzumab beta with low-dose steroids in new-onset ANCA-associated glomerulonephritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm Phase 2 study evaluating the safety and efficacy of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in adults with new-onset ANCA-associated glomerulonephritis. The primary goal is to determine complete remission at Week 24. Eligible participants have biopsy-confirmed pauci-immune GN with active renal involvement and positive PR3-ANCA or MPO-ANCA, and have not received prior B-cell targeted therapy for AAV. The trial will monitor safety signals and treatment responses over the study period. Lead sponsor is Chinese PLA General Hospital in Beijing, with no listed collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chinese PLA General Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Zhe Feng
• Email: zhezhe_4025@126.com
• Phone: +86 010-66935462

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.