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

NCT07746180 | Not Yet Recruiting Phase 2

• 1 other identifier: S2026-448-02
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

ANCA-Associated Glomerulonephritis (AAGN); ANCA-Associated Vasculitis (AAV)

Keywords

ANCA-Associated Glomerulonephritis (AAGN); Obinutuzumab beta; Glucocorticoid

Outcome Measures

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

  Month 6 (Week 24)

Secondary Outcomes (8)

• Renal Remission (RR) rate

  Up to Month 12

• Change in estimated Glomerular Filtration Rate (eGFR)

  Up to Month 12

• Change in proteinuria

  Up to Month 12

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

  Up to Month 12

• Overall Remission rate

  Up to Month 12

Study Arms (1)

Obinutuzumab beta + Glucocorticoid

EXPERIMENTAL

Participants receive Obinutuzumab beta intravenous infusion during induction phase, combined with oral glucocorticoids following a prespecified rapid tapering schedule aiming for complete discontinuation by Week 24.

Drug: Obinutuzumab beta; Drug: Glucocorticoids

Interventions

Obinutuzumab beta DRUG

Intravenous infusion of Obinutuzumab beta administered during the induction phase.

Also known as: MIL62

Obinutuzumab beta + Glucocorticoid

Glucocorticoids DRUG

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

Obinutuzumab beta + Glucocorticoid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Interventions

Glucocorticoids

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Zhe Feng

CONTACT

+86 010-66935462; zhezhe_4025@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor, Department of Nephrology, Chinese PLA General Hospital

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 4, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share