Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04745728
Status:
RECRUITING
Last Update Posted:
2022-04-20
First Post:
2021-02-04
Brief Title:
Different Immunosuppressive Treatment in iMN
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Different Immunosuppressive Treatment in Idiopathic Membranous Nephropathy a Prospective Cohort
Status:
RECRUITING
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
To date the first-line immunosuppressive immunosuppressive therapy of iMN includes corticosteroids combined with cyclophosphamide or rituximab RTX In recent randomized trials MENTOR GEMRITUX the long-term remission rate of RTX is about 60 which is similar to the remission rate of cyclophosphamide combined with corticosteroids in early studies But there is only one published randomized trial STARMEN comparing the efficacy of the two protocols head-to-head In STRAMEN trial the long-term remission rate of cyclophosphamidecorticosteroids group was 83 which was significantly higher than the that 58 of the tacrolimus-RTX group But in STRAMEN trial only one single dose of RTX was given which might influence the efficacy of the tacrolimus-RTX arm Therefore head-to-head comparison of RTX more than one dose and cyclophosphamidecorticosteroid is needed The optimal dose of RTX in the treatment of iMN is unclear In MENTOR trial RTX was given 1g on D1 and D15 and the rate of complete remission at 6 month was 0 so RTX was repeated at 6 month Based on the experience of our center most patients need at least one repeated dose of RTX at 6 month
Based on the previous rationale the investigators designed this study to compare the efficacy of cyclophosphamide plus corticosteroids with RTX in the treatment of iMN
Based on the previous rationale the investigators designed this study to compare the efficacy of cyclophosphamide plus corticosteroids with RTX in the treatment of iMN
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None