Different Immunosuppressive Treatment in iMN
Different Immunosuppressive Treatment in Idiopathic Membranous Nephropathy: a Prospective Cohort
Peking Union Medical College Hospital
200 participants
Apr 14, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria5
- 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.
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Interventions
1mg/kg/d p.o.which will be tapered after 2 months and discontinued over a 6-12 month period.
1-2mg/kg/d p.o. with a target accumulated dose of 12g.
1000mg I.V. on D1 and at 6 month. After 6 month, in patients with response but not 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 repeated on the 15th day of each Rituximab infusion if CD19+ B cell count\>5/ul.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04745728