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Recruiting Phase 2/3

Combination of Rituximab and Cyclosporine in the Treatment of Primary Membranous Nephropathy

NCT07861204 · tracked via the Priya Life Science China tracker
Phase
Phase 2/3
Started
2026-01-21
Last updated
2026-10-06

Condition(s) studied

Membranous Nephropathy

Investigational drug(s) / intervention(s)

Rituximab combined with cyclosporineAll Rituximab trials (254) →All Cyclosporine trials (12) →rituximab →

Rituximab combined with cyclosporine: The first cycle of rituximab was given at a dose of 1000 mg i.v. on day 1 and day 15.Patients were retreated with rituximab (1000mg ) when CD20 B-cell count was more than 5 cells/ml.Oral cyclosporine will be started at 3 mg/kg/day and continued for 6 months, followed by a 2-month tapering period.

rituximab: The first cycle of rituximab was given at a dose of 1000 mg i.v. on day 1 and day 15.Patients were retreated with rituximab (1000mg ) when CD20 B-cell count was more than 5 cells/ml.

Study summary

High-grade proteinuria is one of the key determinants of adverse renal prognosis in patients with primary membranous nephropathy (PMN).The main purpose of this study is to determine whether Rituximab combined with Cyclosporine is superior to Rituximab monotherapy in inducing remission of proteinuria in patients with PMN.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-80 years. 2. Primary membranous nephropathy confirmed by renal biopsy. 3. 24-hour urinary protein quantification \> 5.0 g/24h and serum albumin \< 30 g/L after at least 3 months of treatment with RAAS blockers. 4. eGFR ≥ 40 mL/min/1.73 m². 5. Well-controlled blood pressure (≤140/90 mmHg) in the recent 3 months. 6. Signed informed consent form. Exclusion Criteria: 1. Secondary causes of membranous nephropathy, such as that secondary to systemic lupus erythematosus, malignant tumors, hepatitis B virus infection, heavy metal poisoning; 2. Coexistence of other types of kidney diseases; 3. Use of rituximab within the past 12 months; 4. Use of corticosteroids, cyclophosphamide, cyclosporine, mycophenolate mofetil, or leflunomide within the past 3 months; 5. Active infection: active tuberculosis, HBsAg positivity or HBV-DNA indicating viral replication, positive HCV antibody, HIV infection; 6. New-onset cardiovascular or cerebrovascular diseases within the past 3 7. Severe liver disease: AST and ALT \> 3 times range upper limit ; 8. Uncontrolled severe hypertension; 9. Newly diagnosed or recurrent malignant tumors within the past 5 years; 10. Coexistent autoimmune diseases; 11. Pregnancy, lactation, or recent plans for pregnancy; 12. Life expectancy less than 12 months; 13. Participation in other clinical trials within the past 3 months; 14. Unwillingness to sign the informed consent form; 15. Any other condition deemed unsuitable for the study by the investigator.

Primary outcome measure(s)

  • Remission Status — At 3 months after randomization
    the proportion of subjects to reach the composite of maintaining complete remission or partial remission at 3 months after randomization

Trial sites (1)

FacilityCityRegionStatus
Peking University First Hospital Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07861204 on ClinicalTrials.gov ↗ ← All trials in China