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

October 2, 2026 updated by: Zhao CUI, Peking University First Hospital

Efficacy and Safety of Rituximab Combined With Cyclosporine for Primary Membranous Nephropathy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary membranous nephropathy (PMN) is one of the most common causes of nephrotic syndrome among Chinese adults. For patients with high-grade proteinuria , immunosuppressive therapy is needed. B cell-depleting agent Rituximab is a recommended treatment Regimen in maintaining remission but the response to Rituximab is relatively slow. Calcineurin inhibitors lead to earlier reductions in proteinuria but presenting higher relapse rates in the long follow-up period.Combination therapy may provide both earlier proteinuria remission and durable effect. This is a multi-center, randomized, open-label study conducted in adult patients with biopsy-proven 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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: combination therapy

Rituximab combined with cyclosporine
Drug: 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.
Active Comparator: monotherapy

Rituximab
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission Status
Time Frame: 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
At 3 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission at 6 months and 12 months
Time Frame: From enrollment to the end of follow-up at 12 months

The proportions of patients achieving complete remission or partial remission at 6 and 12 months of treatment.
From enrollment to the end of follow-up at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Fu Xing Hospital, Capital Medical University
China Rehabilitation Research Center
People's Hospital of Beijing Daxing District

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

October 2, 2026

First Posted (Actual)

October 6, 2026

Study Record Updates

Last Update Posted (Actual)

October 6, 2026

Last Update Submitted That Met QC Criteria

October 2, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ricyclo-pMN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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