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Prospective, Multicenter, Single-Arm Clinical Study of Eculizumab Combined with CD20-Targeted Antibody in the Treatment of Anti-Glomerular Basement Membrane (Anti-GBM) Antibody-Associated Glomerulonephritis

Prospective, Multicenter, Single-Arm Clinical Study of Eculizumab Combined with CD20-Targeted Antibody in the Treatment of Anti-Glomerular Basement Membrane (Anti-GBM) Antibody-Associated Glomerulonephritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116985
Enrollment
Unknown
Registered
2026-01-18
Start date
2026-01-19
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-Glomerular Basement Membrane (Anti-GBM) Antibody-Associated Glomerulonephritis

Interventions

Sponsors

The First Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years and 30% or creatinine clearance decreased by >25% within the past 4 weeks, after exclusion of other causes and attributed to active nephritis). 4.Patients or their legal representatives must provide written informed consent prior to any study-specific examinations or procedures.

Exclusion criteria

Exclusion criteria: 1.Failure to sign a written informed consent form or inability/unwillingness to comply with the study protocol as determined by the investigator. 2.History of cardiovascular or cerebrovascular events (such as myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association Class II–IV heart failure, stroke, etc.) or infection events requiring hospitalization within the past 12 weeks. 3.Known allergy to any component of anti-CD20 monoclonal antibodies and eculizumab. 4.Congenital or acquired immunodeficiency, or patients with concurrent active infections such as active hepatitis, active tuberculosis, or active cytomegalovirus (CMV) infection. 5.Patients with other serious physiological or psychological conditions deemed unsuitable for participation by the investigator.

Design outcomes

Primary

MeasureTime frame
24-week Complete Renal Remission Rate (CRR);

Secondary

MeasureTime frame
Kidney survival rate;Cumulative doses of prednisone and cyclophosphamide;

Countries

China

Contacts

Public ContactHan Fei

Kidney Disease Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

hanf8876@zju.edu.cn+86 139 6819 3317

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026