Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome

Phase 3

Completed

• Conditions: Nephrotic Syndrome
• Interventions: Drug: acid mycophenolic (Myfortic); Drug: Prednisone

• Registration Number: NCT01197040
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 mg/kg/day (arm A) or 0,5 mg/kg/day plus myforticR 1440 mg/day (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 mg/kg/day 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 0.5 mg/kg/day combined with mycophenolic acid (MyforticR) 1440 mg/day. 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-09-07
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-09
• Primary Completion: 2014-07
• Study Completion: 2015-06
• Status Verified: 2015-10
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

• Idiopathic nephrotic syndrome
• Flare of idiopathic syndrome without treatment from one year
• Confirming by Renal Biopsy

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Exclusion Criteria

• Secondary nephrotic syndrome
• Pregnancy
• Focal Segmental Glomerular sclerosis lesion in the Biopsy
• Neutropenia < 2000/mm3
• Hb<9gr/dl

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B-Experimental	acid mycophenolic (Myfortic)	Experimental
A-Active Comparator	Prednisone	Active Comparator

Primary Outcome Measures

Name	Time	Method
complete remission	within 4 weeks	complete remission

Secondary Outcome Measures

Name	Time	Method
complete remission	within 8 weeks	complete remission
partial remission	within 4 and 8 weeks	partial remission
Adverse effects in both arms	1 year	Adverse effects in both arms
Number of flare in both arms	at 1 year	Number of flare in both arms

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, Val de Marne, France