Rituximab plus Cyclosporine for Primary Membranous Nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, randomized, open-label phase 2/3 trial in adults with biopsy-proven primary membranous nephropathy and high-grade proteinuria. Participants receive Rituximab with Cyclosporine versus Rituximab alone to see which approach better reduces proteinuria and sustains remission. The trial aims to balance earlier proteinuric response from Cyclosporine with the durable effect of Rituximab. Eligibility requires age 18-80, confirmed PMN, substantial proteinuria after optimized RAAS blockade, adequate kidney function, controlled blood pressure, and informed consent. The study is led by Peking University First Hospital with several collaborating centers in China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University First Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Fang Wang, Doctor
• Email: wangfang@bjmu.edu.cn
• Phone: 01083572388

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HLX79 with rituximab (HLX01) for active glomerulonephritis

  This trial will test whether adding HLX79 at different doses to rituximab (HLX01) helps adults with active membranous nephropathy or lupus nephritis.

  Recruiting Phase 2 Shanghai Henlius Biotech · Beijing and 16 other locations · NCT07038382

• AI-guided personalized rituximab for membranous nephropathy

  This trial will test whether an AI-guided approach to dosing rituximab improves remission in adults with PLA2R1-positive nephrotic membranous nephropathy.

  Recruiting at 13 sites Phase 3 Centre Hospitalier Universitaire de Nice · Besançon and 13 other locations · NCT06341205

• Long-term outcomes in primary membranous nephropathy

  This project will follow adults with primary membranous nephropathy and nephrotic syndrome to see how their disease and real-world treatments affect long-term kidney outcomes.

  Recruiting Mario Negri Institute for Pharmacological Research · Bergamo, BG and 1 other locations · NCT06242327

• Combining belimumab and rituximab for treating primary membranous nephropathy

  This study is testing if combining two medications, belimumab and rituximab, can help adults with primary membranous nephropathy feel better and achieve remission more effectively than using rituximab alone.

  Recruiting at 20 sites Phase 2 National Institute of Allergy and Infectious Diseases (NIAID) · Birmingham, Alabama and 19 other locations · NCT03949855

• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

  This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.

  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07908888

• Chidamide, Lenalidomide, and Rituximab as induction therapy for newly diagnosed elderly or unfit double-expressor DLBCL

  This trial tests whether the combo of chidamide, lenalidomide, and rituximab can help treat newly diagnosed double-expressor DLBCL in people who are elderly or not fit for standard chemotherapy.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07884708

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.