Comparing immunosuppressive treatments for idiopathic membranous nephropathy
Different Immunosuppressive Treatment in Idiopathic Membranous Nephropathy: a Prospective Cohort
This study is testing two different treatments for idiopathic membranous nephropathy to see which one helps patients feel better and stay well longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | rituximab, cyclophosphamide |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04745728 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two different immunosuppressive therapies for treating idiopathic membranous nephropathy (iMN) over a 24-month period. The therapies being compared are a combination of corticosteroids and cyclophosphamide versus rituximab, with a focus on determining the optimal dosing of rituximab. Previous studies have shown varying remission rates for these treatments, and this trial seeks to clarify which approach yields better long-term outcomes. Participants will be monitored for proteinuria levels and overall remission status throughout the study duration.
Who should consider this trial
Good fit: Ideal candidates for this study are post-menopausal women with idiopathic membranous nephropathy who meet specific health criteria.
Not a fit: Patients with active infections, secondary causes of nephropathy, or those who have previously shown resistance to the treatments being tested may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the most effective treatment for patients with idiopathic membranous nephropathy, potentially leading to higher remission rates.
How similar studies have performed: Previous studies have shown varying success rates for similar treatment approaches, but this trial aims to provide a more definitive head-to-head comparison.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * idiopathic membranous nephropathy * Female, must be post-menopausal, sterile or have effective contraception * must be off steroid or mycophenolate mofetil for \>1 month and alkylating agents for or RTX\> 6 months * Angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for ≥ 3 months with controlled blood pressure prior to beginning of immunosuppressive therapy or if patients are intolerant to ACEI/ARB. * proteinuria ≥4g/24h and decreased ≤ 50% from baseline Exclusion Criteria: * presence of active infection or a secondary cause of membranous nephropathy * proteinuria associated with diabetic nephropathy * pregnancy or breast feeding * history of resistance to rituximab or alkylating agents or corticosteroid * Patients who previously achieved remission after treatment of rituximab or alkylating agents but relapsed off rituximab or alkylating agents after 6 months are eligible.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Yan Qin — Peking Union Medical College Hospital
- Study coordinator: Sanxi Ai
- Email: sanxiai@163.com
- Phone: 18811054896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.