Spontaneous remission of nephrotic syndrome in idiopathic membranous nephropathy.
Natalia Polanco, Elena Gutiérrez, Adelardo Covarsí...
https://pubmed.ncbi.nlm.nih.gov/20110379Actively Recruiting
Phase 3
Age: 18Years - 80Years
All Genders
ID04745728
Different Immunosuppressive Treatment in Idiopathic Membranous Nephropathy: a Prospective Cohort
Led by Peking Union Medical College Hospital · Updated on 2025-12-09
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of different immunosuppressive treatments in adults with idiopathic membranous nephropathy (iMN), a kidney condition. This study compares the long-term remission rates at 24 months between two main treatments: cyclophosphamide combined with corticosteroids and rituximab (RTX). Previous trials showed varying remission rates, and this study aims to clarify which treatment approach offers better outcomes, especially considering repeated doses of RTX may improve response. Participants receive one of two treatment plans. The first involves prednisone at 1mg/kg/day orally, tapered after 2 months and stopped over 6 to 12 months, plus cyclophosphamide at 1-2mg/kg/day with a total dose target of 12g. Optional medications like azathioprine or mycophenolate mofetil may be given if remission is not achieved by 6 months. The second plan uses rituximab 1000mg intravenously on Day 1 and at 6 months, with possible repeated doses every 6 months for patients who respond but do not fully remit. Rituximab dosing may be adjusted based on CD19+ B cell counts. Optional calcineurin inhibitors are tapered and stopped by 9 months. Throughout the study, participants are monitored for remission status at multiple time points up to 24 months, kidney function changes, relapse rates, and levels of relevant blood markers such as anti-PLA2R and CD19+ B cells. Safety and adverse events are recorded during the entire period. This prospective cohort study allows researchers to compare how these treatments perform and assess the time to remission and kidney health over two years.
CONDITIONS
Brief Title
Different Immunosuppressive Treatment in iMN
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with idiopathic membranous nephropathy
- Female participants must be post-menopausal, sterile, or using effective contraception
- Off steroids or mycophenolate mofetil for more than 1 month and off alkylating agents or rituximab for more than 6 months
- Taking an ACE inhibitor or angiotensin receptor blocker for at least 3 months with controlled blood pressure, or intolerant to these medications
- Proteinuria of at least 4g per 24 hours and decreased by no more than 50% from baseline
You will not qualify if you...
- Active infection or secondary cause of membranous nephropathy
- Proteinuria caused by diabetic nephropathy
- Pregnancy or breastfeeding
- History of resistance to rituximab, alkylating agents, or corticosteroids
- Patients who previously achieved remission after rituximab or alkylating agents but relapsed after more than 6 months off these treatments are eligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 24 months
Participants receive immunosuppressive treatment with either cyclophosphamide plus prednisone or rituximab. Prednisone is taken orally and tapered over 6-12 months. Cyclophosphamide is taken orally with a target accumulated dose of 12g. Rituximab is given intravenously on Day 1 and at 6 months, with possible repeated doses every 6 months until complete remission.
Multiple visits for treatment infusions and monitoring over 24 months
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
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Research Team
S
Sanxi Ai
Y
Yan Qin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Rituximab for Severe Membranous Nephropathy: A 6-Month Trial with Extended Follow-Up.
Karine Dahan, Hanna Debiec, Emmanuelle Plaisier...
https://pubmed.ncbi.nlm.nih.gov/27352623Rituximab or Cyclosporine in the Treatment of Membranous Nephropathy.
Fernando C Fervenza, Gerald B Appel, Sean J Barbour...
https://pubmed.ncbi.nlm.nih.gov/31269364Safety of Rituximab Compared with Steroids and Cyclophosphamide for Idiopathic Membranous Nephropathy.
Jan A J G van den Brand, Piero Ruggenenti, Antonietta Chianca...
https://pubmed.ncbi.nlm.nih.gov/28487395The STARMEN trial indicates that alternating treatment with corticosteroids and cyclophosphamide is superior to sequential treatment with tacrolimus and rituximab in primary membranous nephropathy.
Gema Fernández-Juárez, Jorge Rojas-Rivera, Anne-Els van de Logt...
https://pubmed.ncbi.nlm.nih.gov/33166580Retreatment with rituximab for membranous nephropathy with persistently elevated titers of anti-phospholipase A2 receptor antibody.
K Dahan, C Johannet, E Esteve...
https://pubmed.ncbi.nlm.nih.gov/30606419