Ignite Creation Date:
2024-05-05 @ 10:50 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01197040
Status:
COMPLETED
Last Update Posted:
2017-06-28
First Post:
2010-09-07
Brief Title:
Evaluation of Low Dose Corticosteroids Efficiency Associated With Myfortic in the Treatment of Nephrotic Syndrome
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Low Steroid Dose Combined With Mycophenolic Acid Myfortic Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome
Status:
COMPLETED
Status Verified Date:
2015-10
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:
MSN
Brief Summary:
A multicenter randomized study will be performed to evaluate the efficacy of low dose steroid combined with mycophenolic acid MyforticR versus high dose steroid in inducing remission in adults with minimal change nephrotic syndrome MCNS One hundred and fourteen patients CPP decision 2009-04-02-a5 will be included in this study They will be randomly assigned to an open label treatment with either prednisone
1 mgkgday arm A or 05 mgkgday plus myforticR 1440 mgday arm B for four weeks The outcome will be compared during one-year follow up
1 mgkgday arm A or 05 mgkgday plus myforticR 1440 mgday arm B for four weeks The outcome will be compared during one-year follow up
Detailed Description:
The treatment for minimal change nephrotic syndrome MCNS is empirically based on high dose steroid However the side effects in adult patients are often significant and induce a lot of complications This prospective study aimed to compare low dose steroid combined with mycophenolic acid MyforticR versus high dose steroid in the treatment of the first episode of MCNS
Treatment Plan
After baseline evaluation including clinical biological and histological analyses all eligible patients will be an open label assigned to two groups
Group A patients will receive prednisone 1 mgkgday for 4 weeks Then the dose will be progressively tapered if the remission will be achieved For patients who exhibit incomplete remission at this time high dose steroid will be continued for 4 weeks again before the tapering
Group B patients will receive prednisone 05 mgkgday combined with mycophenolic acid MyforticR 1440 mgday The management of steroid therapy will be identical in both groups while MyforticR will be continued for six months
In both groups patients who will not achieve remission after 8 weeks of steroid therapy at full dose will be excluded from the study
Statistical Analysis In this multicenter randomized trial the primary and secondary end points will be the rate of complete remission within 4 and 8 weeks of the start of induction therapy respectively
Treatment Plan
After baseline evaluation including clinical biological and histological analyses all eligible patients will be an open label assigned to two groups
Group A patients will receive prednisone 1 mgkgday for 4 weeks Then the dose will be progressively tapered if the remission will be achieved For patients who exhibit incomplete remission at this time high dose steroid will be continued for 4 weeks again before the tapering
Group B patients will receive prednisone 05 mgkgday combined with mycophenolic acid MyforticR 1440 mgday The management of steroid therapy will be identical in both groups while MyforticR will be continued for six months
In both groups patients who will not achieve remission after 8 weeks of steroid therapy at full dose will be excluded from the study
Statistical Analysis In this multicenter randomized trial the primary and secondary end points will be the rate of complete remission within 4 and 8 weeks of the start of induction therapy respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None