Evaluation of Low Dose Corticosteroids Efficiency, Associated With

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01197040
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact
Status	Completed
Phase	Phase 3
Start date	October 2009
Completion date	June 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms