Status:
TERMINATED
Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMN
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Beijing Tongren Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions:
Idiopathic Membranous Nephropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to determine whether or not cyclosporine (CsA) combined with RTX is more effective than RTX alone in the treatment of idiopathic membranous nephropathy (iMN).
Detailed Description
To date, the first-line immunosuppressive therapy of iMN includes corticosteroids combined with cyclophosphamide or Rituximab (RTX) which has been used more and more widely due to superior safety prof...
Eligibility Criteria
Inclusion
- idiopathic MN with or without diagnostic biopsy
- Female, must be post-menopausal, sterile or have effective method of contraception
- must be off steroid or mycophenolate mofetil for \>1 month and alkylating agents for \> 6 months
- Angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for ≥3 months prior to randomization with controlled blood pressure or if patients is intolerant to ACEI/ARB
- proteinuria ≥4g/24h using the average from two 24-hour urine samples collected within 2 weeks of each other, and decreased ≤50% from baseline.
- estimated glomerular filtration rate (eGFR) ≥40ml/min/1.73m2
Exclusion
- presence of active infection or a secondary cause of MN
- diabetes mellitus: to exclude proteinuria secondary to diabetic nephropathy.
- pregnancy or breast feeding
- history of resistance to CsA or other calcineurin inhibitors(CNI), RTX or alkylating agents.
- Patients who previously achieved remission after treatment of CNI, RTX or alkylating agents but relapsed off CNI after 3 months, or relapsed off RTX or alkylating agents after 6 months, are eligible.
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04743739
Start Date
April 14 2021
End Date
December 20 2024
Last Update
December 9 2025
Active Locations (7)
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1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100037
2
Beijing Tongren Hospital， Capital Medical University
Beijing, Beijing Municipality, China, 100730
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
4
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 101149