Status:
RECRUITING
Different Immunosuppressive Treatment in iMN
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Idiopathic Membranous Nephropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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)
Detailed Description
To date, the first-line immunosuppressive immunosuppressive therapy of iMN includes corticosteroids combined with cyclophosphamide or rituximab (RTX). In recent randomized trials (MENTOR, GEMRITUX), t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04745728
Start Date
April 14 2021
End Date
December 1 2029
Last Update
December 9 2025
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730