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Not yet recruiting NCT07746180

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

Phase II Interventional ANCA-Associated Glomerulonephritis (AAGN) ANCA-Associated Vasculitis (AAV)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Obinutuzumab beta, Glucocorticoids.
Who it may be relevant to
Registry conditions: ANCA-Associated Glomerulonephritis (AAGN), ANCA-Associated Vasculitis (AAV). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis: A Prospective Exploratory Study

Overview

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).

Detailed description

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). The primary objective is to assess the complete remission rate at Week 24.

Interventions

  • Drug Obinutuzumab beta
    Intravenous infusion of Obinutuzumab beta administered during the induction phase.
  • Drug Glucocorticoids
    Oral glucocorticoid induction starting alongside Obinutuzumab beta, following a prespecified rapid tapering schedule aimed at complete discontinuation by Week 24.

Primary outcome measures

  • Complete Remission (CR) rate [Time frame: Month 6 (Week 24)]
Secondary outcome measures (8)
  • Renal Remission (RR) rate [Time frame: Up to Month 12]
  • Change in estimated Glomerular Filtration Rate (eGFR) [Time frame: Up to Month 12]
  • Change in proteinuria [Time frame: Up to Month 12]
  • Incidence of End-Stage Renal Disease (ESRD) or death [Time frame: Up to Month 12]
  • Overall Remission rate [Time frame: Up to Month 12]
  • Proportion of participants achieving peripheral B-cell depletion [Time frame: Up to Month 12]
  • Change in ANCA serological status and titer levels [Time frame: Up to Month 12]
  • Incidence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to Month 12]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07746180 · S2026-448-02 · S2026-448-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗