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

ConditionsANCA-Associated Glomerulonephritis (AAGN)ANCA-Associated Vasculitis (AAV)
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Obinutuzumab beta

    Drug

    Intravenous infusion of Obinutuzumab beta administered during the induction phase.

  • Glucocorticoids

    Drug

    Oral glucocorticoid induction starting alongside Obinutuzumab beta, following a prespecified rapid tapering schedule aimed at complete discontinuation by Week 24.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Obinutuzumab beta + GlucocorticoidExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Complete Remission (CR) rate

Proportion of participants achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 and complete withdrawal of oral glucocorticoids

Time frame
Month 6 (Week 24)

Secondary outcomes

1

Renal Remission (RR) rate

Proportion of participants achieving renal remission, defined by stabilization or improvement in renal function and resolution of active urinary sediment.

Time frame
Up to Month 12
2

Change in estimated Glomerular Filtration Rate (eGFR)

Dynamic change of eGFR from baseline.

Time frame
Up to Month 12
3

Change in proteinuria

Dynamic change of 24-hour urine protein or Urine Protein-to-Creatinine Ratio (UPCR) from baseline.

Time frame
Up to Month 12
4

Incidence of End-Stage Renal Disease (ESRD) or death

Proportion of participants reaching the composite endpoint of ESRD or all-cause mortality.

Time frame
Up to Month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese PLA General Hospital

Lead sponsor

Source ClinicalTrials.gov
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