Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese PLA General Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Obinutuzumab beta
- Glucocorticoids
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov