Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04743739
Status:
RECRUITING
Last Update Posted:
2021-05-18
First Post:
2021-01-30
Brief Title:
Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMN
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Multicenter Randomized Controlled Trial of Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of Idiopathic Membranous Nephropathy
Status:
RECRUITING
Status Verified Date:
2021-05
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 determine whether or not cyclosporine CsA combined with RTX is more effective than RTX alone in the treatment of idiopathic membranous nephropathy iMN
Detailed Description:
To date the first-line immunosuppressive therapy of iMN includes corticosteroids combined with cyclophosphamide or Rituximab RTX which has been used more and more widely due to superior safety profiles But the long term remission rate of RTX monotherapy is only 60 and it takes effect relatively slowly
2 pilot studies reported that the combination therapy of cyclosporine CsA and RTX had better efficacy for inducing remission for iMN with the long term remission rate up to 85 CsA and RTX may have synergistic effect in the treatment of iMN because they have different time of action and different effects on the immune system and podocytes
Based on the previous rationale the investigators designed this trial to determine whether combination of CsA and RTX is more effective than RTX alone in the treatment of iMN
2 pilot studies reported that the combination therapy of cyclosporine CsA and RTX had better efficacy for inducing remission for iMN with the long term remission rate up to 85 CsA and RTX may have synergistic effect in the treatment of iMN because they have different time of action and different effects on the immune system and podocytes
Based on the previous rationale the investigators designed this trial to determine whether combination of CsA and RTX is more effective than RTX alone 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?:
False
Is an FDA AA801 Violation?:
None