Different Immunosuppressive Treatment in iMN
Idiopathic Membranous Nephropathy
About this trial
This is an interventional treatment trial for Idiopathic Membranous Nephropathy
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.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
cyclophosphamide and prednisone
Rituximab
Prednisone will be given at 1mg/kg/d p.o. and will be tapered after 2 months and discontinued over a 6-12 month period. Cyclophosphamide will be given at 1-2mg/kg/d p.o. with a target accumulated dose of 12g. Azathioprine or mycophenolate mofetil are optional which could be given for a short period of time (<6 months)after discontinuation of cyclophosphamide if patients do not remit at 6 month.
Rituximab 1000mg I.V. on Day1 and at 6 month. After 6 months, in patients with response but without complete remission, Rituximab could be stopped or repeated with a 6 month-interval (12 month, 18 month, 24 month) until complete remission. Rituximab 1000mg I.V. will be given on the 15th day after each Rituximab infusion if CD19+ B cell count>5/ul on the 15th day. Calcineurin inhibitors (CNI) are optional but should be tapered after 6 months and discontinued after 9 months.