NCT04745728 Different Immunosuppressive Treatment in iMN
| NCT ID | NCT04745728 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Idiopathic Membranous Nephropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-04-14 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2021-04-14 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this study is to compare the 24 month remission of different immunosuppressive therapies in the treatment of idiopathic membranous nephropathy (iMN)
Eligibility 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.
Contact & Investigator
Yan Qin
PRINCIPAL INVESTIGATOR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT04745728 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Idiopathic Membranous Nephropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04745728 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT04745728 currently recruiting?
Yes, NCT04745728 is actively recruiting participants. Contact the research team at sanxiai@163.com for enrollment information.
Where is the NCT04745728 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04745728 clinical trial?
NCT04745728 is sponsored by Peking Union Medical College Hospital. The principal investigator is Yan Qin at Peking Union Medical College Hospital. The trial plans to enroll 200 participants.