Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMN
Idiopathic Membranous Nephropathy
About this trial
This is an interventional treatment trial for Idiopathic Membranous Nephropathy focused on measuring Rituximab, cyclosporine, idiopathic membranous nephropathy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Fuwai Hospital, Chinese Academy of Medical Sciences
- Beijing Tongren Hospital, Capital Medical University
- Peking Union Medical College HospitalRecruiting
- Beijing Luhe Hospital, Capital Medical University
- Nanyang Nanshi Hospital, Henan University
- The Seventh Affiliated Hospital, Sun Yat-sen University
- The First Affiliated Hospital of Xinjiang Medical University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Rituximab monotherapy
Rituximab combined with cyclosporine
Rituximab 1000mg I.V. on Days 1 and 181, and will be retreated or not on Days 15 and 195 according to the CD19+ B cells count.
Rituximab 1000mg I.V. on Days 1 and 181, and will be retreated or not on Days 15 and 195 according to CD19+ B cells count. cyclosporine (CsA) will be started at a dose of 3mg/kg/day p.o. divided into 2 equal doses given at 12 hour intervals. Doses of CsA will be adjusted according to the blood levels of CsA. CsA will be tapered after 6 months and discontinued over a 3 month period.