Prospective, Multicenter, Single-Arm Clinical Study of Eculizumab Combined with CD20-Targeted Antibody in the Treatment of Active Proliferative Lupus Nephritis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600122544

Enrollment

Unknown

Registered

2026-04-15

Start date

2026-04-15

Completion date

Unknown

Last updated

2026-04-20

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

Conditions

Lupus Nephritis

Interventions

Experimental group:Eculizumab Combined with Anti-CD20 Monoclonal Antibodies

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years and 1.0 g/day, hematuria >5/HP, serum creatinine increase >30% within 4 weeks or creatinine clearance decrease >25%, excluding other causes and considered due to lupus nephritis activity; 4. Women of childbearing potential must have a negative pregnancy test, and both men and women must use appropriate contraception; 5. The patient or their legal representative must provide written informed consent before undergoing any research-specific examinations or procedures.

Exclusion criteria

Exclusion criteria: 1.Failure to provide written informed consent or inability/unwillingness to comply with the study protocol as determined by the investigator. 2.History of cardiovascular or cerebrovascular events (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 or eculizumab. 4.Congenital or acquired immunodeficiency, or 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

Measure	Time frame
24-week Complete Renal Remission Rate (CRR);	—

Secondary

Measure	Time frame
Renal Remission Rate ;complement levels;Anti-dsDNA antibody titers;SLEDAI-2K score;Magnitude of corticosteroid reduction / Degree of glucocorticoid tapering;	—

Countries

China

Contacts

Public ContactHan Fei

The First Affiliated Hospital of Zhejiang University School of Medicine

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

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026