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

 -  Idiopathic nephrotic syndrome

 -  Flare of idiopathic syndrome without treatment from one year

 -  Confirming by Renal Biopsy

 Exclusion Criteria:

 -  Secondary nephrotic syndrome

 -  Pregnancy

 -  Focal Segmental Glomerular sclerosis lesion in the Biopsy

 -  Neutropenia < 2000/mm3

 -  Hb<9gr/dl