Ignite Creation Date:
2024-05-06 @ 1:16 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03970577
Status:
UNKNOWN
Last Update Posted:
2021-07-13
First Post:
2019-04-15
Brief Title:
RItuximab From the FIRst Episode of Idiopathic Nephrotic Syndrome
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Rituximab From the First Episode of Minimal Change Nephrotic Syndrome for Preventing Relapse Risk in Adult Patients a Multicenter Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
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:
RIFIREINS
Brief Summary:
Minimal change nephrotic syndrome MCNS is an acquired glomerular disease characterized by massive proteinuria occurring in the absence of glomerular inflammatory lesions or immunoglobulin deposits MCNS represents a frequent cause of nephrotic syndrome NS in adults 10 to 25 of cases The disease typically takes a chronic course characterized by frequent relapses Until now exclusive oral steroid therapy at the dose of 1mgkgday max 80 mgday for a minimum of 4 weeks and a maximum of 16 weeks as tolerated constitutes the first line treatment of adults with MCNS Despite of successful remission of initial episode previous case series showed that 56-76 of patients experience at least one relapse after steroid-induced remission The recent MSN trial prospectively showed that 579 and 70 of adult patients were in complete remission CR after 4 and 8 weeks of oral steroids therapy 1mgkgday Among them 231 of patients displayed at least one relapse episode after one year-follow-up Although well tolerated side effects are common in patients with prolonged andor repeated courses of steroids and alternative regimens seem highly suitable to reduce the risk of subsequent relapse Rituximab has recently emerged as a promising therapeutic option in patients with steroids dependent-MCNS In a multicenter double-blind randomized placebo-controlled trial in children with frequent relapse or with steroid dependent NS the authors found that the median relapse free period was significantly longer in the Rituximab group than in the placebo group without significant differences concerning serious adverse events To our knowledge its use has never been investigated for the initial episode of MCNS with the aim to reduce the subsequent risk of relapse that is a major concern in the management of MCNS patients
The main objective is to demonstrate from initial episode of MCNS in adults once complete remission has occurred that the use of Rituximab two injections separated by one week 375mgm2 with definitive steroids withdrawal after 9 weeks of treatment may reduce the risk of subsequent MCNS relapse after 12 months of follow-up and may be a safe and an efficient treatment regimen
The study will be a single stage phase IIb randomized open-label parallel group in a 11 ratio active controlled multicenter trial testing the efficacy and safety of two injections of Rituximab separated by one week 375mgm2 from initial episode of biopsy-proven MCNS in adults Since Rituximab therapy when initiated in a context of steroid dependency MCNS seems to be more effective in patients with complete remission and because of recent data from MSN trial showing that 70 of patients were in complete remission of nephrotic syndrome after 8 weeks of steroids we decided to maximize the potential benefit to perform randomization of patients after 8 weeks of steroid treatment A potential risk factor of relapse is the time of CR occurrence and because some patients reach CR at 4 weeks and others at 8 weeks a randomization 11 with minimization strategy will be done in order to balance this factor between arms The primary endpoint will be the incidence of MCNS relapse during the 12 months following randomization defined by the recurrence of nephrotic syndrome urine proteincreatinine ratio UPCR 300mgmmol and decreased albumin level 30 gL in a patient who was in complete remission
Rituximab is currently considered as an effective therapeutic option to maintain remission in patients with frequently relapsing nephrotic syndrome FRNS or steroid-dependent nephrotic syndrome SDNS The goal of this prospective study is to determine the potential interest of the use of Rituximab from the initial episode of MCNS to reduce the risk of subsequent relapse that is a major concern in the management of MCNS patients
The main objective is to demonstrate from initial episode of MCNS in adults once complete remission has occurred that the use of Rituximab two injections separated by one week 375mgm2 with definitive steroids withdrawal after 9 weeks of treatment may reduce the risk of subsequent MCNS relapse after 12 months of follow-up and may be a safe and an efficient treatment regimen
The study will be a single stage phase IIb randomized open-label parallel group in a 11 ratio active controlled multicenter trial testing the efficacy and safety of two injections of Rituximab separated by one week 375mgm2 from initial episode of biopsy-proven MCNS in adults Since Rituximab therapy when initiated in a context of steroid dependency MCNS seems to be more effective in patients with complete remission and because of recent data from MSN trial showing that 70 of patients were in complete remission of nephrotic syndrome after 8 weeks of steroids we decided to maximize the potential benefit to perform randomization of patients after 8 weeks of steroid treatment A potential risk factor of relapse is the time of CR occurrence and because some patients reach CR at 4 weeks and others at 8 weeks a randomization 11 with minimization strategy will be done in order to balance this factor between arms The primary endpoint will be the incidence of MCNS relapse during the 12 months following randomization defined by the recurrence of nephrotic syndrome urine proteincreatinine ratio UPCR 300mgmmol and decreased albumin level 30 gL in a patient who was in complete remission
Rituximab is currently considered as an effective therapeutic option to maintain remission in patients with frequently relapsing nephrotic syndrome FRNS or steroid-dependent nephrotic syndrome SDNS The goal of this prospective study is to determine the potential interest of the use of Rituximab from the initial episode of MCNS to reduce the risk of subsequent relapse that is a major concern in the management of MCNS patients
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-003437-15 | EUDRACT_NUMBER | None | None |