Different Immunosuppressive Treatment in Idiopathic Membranous Nephropathy: a Prospective Cohort
Who is this study for? Patients with Idiopathic Membranous Nephropathy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Sanxi Ai
sanxiai@163.com
18811054896
Backup
Yan Qin
qinyanbeijing@126.com
Time Frame
Start Date: 2021-04-14
Estimated Completion Date: 2027-03
Participants
Target number of participants: 200
Treatments
Active_comparator: cyclophosphamide and prednisone
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.
Active_comparator: Rituximab
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.
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital