Membranous NephropathyPhase 2/3NCT07861204
Combination of Rituximab and Cyclosporine in the Treatment of Primary Membranous Nephropathy
A Phase 2/3 study testing Rituximab combined with cyclosporine and rituximab in people with Membranous Nephropathy, run by Peking University First Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Membranous Nephropathy
- What is being tested?
- Rituximab combined with cyclosporine and rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2026to 30 Dec 2027
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years.
- Primary membranous nephropathy confirmed by renal biopsy.
- 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.
- eGFR ≥ 40 mL/min/1.73 m².
- Well-controlled blood pressure (≤140/90 mmHg) in the recent 3 months.
- Signed informed consent form.
Who cannot join
- Secondary causes of membranous nephropathy, such as that secondary to systemic lupus erythematosus, malignant tumors, hepatitis B virus infection, heavy metal poisoning;
- Coexistence of other types of kidney diseases;
- Use of rituximab within the past 12 months;
- Use of corticosteroids, cyclophosphamide, cyclosporine, mycophenolate mofetil, or leflunomide within the past 3 months;
- Active infection: active tuberculosis, HBsAg positivity or HBV-DNA indicating viral replication, positive HCV antibody, HIV infection;
- New-onset cardiovascular or cerebrovascular diseases within the past 3
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- Severe liver disease: AST and ALT > 3 times range upper limit ;
- Uncontrolled severe hypertension;
- Newly diagnosed or recurrent malignant tumors within the past 5 years;
- Coexistent autoimmune diseases;
- Pregnancy, lactation, or recent plans for pregnancy;
- Life expectancy less than 12 months;
- Participation in other clinical trials within the past 3 months;
- Unwillingness to sign the informed consent form;
- Any other condition deemed unsuitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing
Fang Wang, 86-10-83572388, wangfang@bjmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Membranous Nephropathy
- Being tested
- Rituximab combined with cyclosporine, rituximab
- Keywords
- membranous nephropathy, Rituximab, Cyclosporine
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab combined with cyclosporineDrug
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.
rituximabDrug
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 group | Role | What they receive |
|---|---|---|
| combination therapy | Active comparator | Rituximab combined with cyclosporine Receives: Drug: Rituximab combined with cyclosporine |
| monotherapy | Active comparator | Rituximab Receives: Drug: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission Status
the proportion of subjects to reach the composite of maintaining complete remission or partial remission at 3 months after randomization
Measured: At 3 months after randomization
Secondary outcomes (1)
Remission at 6 months and 12 months
The proportions of patients achieving complete remission or partial remission at 6 and 12 months of treatment.
Measured: From enrollment to the end of follow-up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start21 Jan 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Membranous NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Rehabilitation Research Center, Fu Xing Hospital, Capital Medical University, People's Hospital of Beijing Daxing District
- Responsible party
- Principal investigator, Zhao CUI, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861204
- Sponsor's protocol ID
- Ricyclo-pMN
- Status last verified
- Oct 2026
- First submitted
- 12 Feb 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No