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NCT Number: NCT07746180

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

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).

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Key information

Conditions

ANCA-Associated Glomerulonephritis (AAGN) ANCA-Associated Vasculitis (AAV) Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Cardiovascular Diseases Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Obinutuzumab beta

Drug

Intravenous infusion of Obinutuzumab beta administered during the induction phase.

Other names: MIL62

Glucocorticoids

Drug

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

Primary outcomes

  1. Complete Remission (CR) rate

    Time frame: Month 6 (Week 24)

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

Secondary outcomes

  1. Renal Remission (RR) rate

    Time frame: Up to Month 12

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

  2. Change in estimated Glomerular Filtration Rate (eGFR)

    Time frame: Up to Month 12

    Dynamic change of eGFR from baseline.

  3. Change in proteinuria

    Time frame: Up to Month 12

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

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

    Time frame: Up to Month 12

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

  5. Overall Remission rate

    Time frame: Up to Month 12

    Proportion of participants achieving a BVAS of 0.

  6. Proportion of participants achieving peripheral B-cell depletion

    Time frame: Up to Month 12

    Pharmacodynamic assessment of peripheral B-cell count changes from baseline.

  7. Change in ANCA serological status and titer levels

    Time frame: Up to Month 12

    Proportion of participants achieving ANCA negativity and changes in ANCA titers from baseline.

  8. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to Month 12

    Safety and tolerability evaluated by the number and severity of AEs graded according to CTCAE v6.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhe Feng

CONTACT

[email protected]

+86 010-66935462

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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