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

Condition(s) targeted: Nephrotic Syndrome

Intervention: acid mycophenolic (Myfortic) (Drug); acid mycophenolic (Myfortic) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Philippe REMY, MD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris

Overall contact:
Philippe REMY, MD, Phone: (0)1 49 81 24 59, Ext: +33, Email: philippe.remy@hmn.aph.fr

A multicenter, randomized, double-blind, prospective 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). Two hundred patients will be included in this study. They will be randomly assigned to a double blind 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

Official title: Low Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: complete remission

Secondary outcome:

complete remission

partial remission

Adverse effects in both arms

Number of flare in both arms

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.

Patients and methods: two hundred patients will be included in this study. They will be randomly assigned to a double blind treatment

Treatment Plan

After baseline evaluation including clinical biological and histological analyses, all eligible patients will be double-blind 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Philippe REMY, MD, Phone: (0)1 49 81 24 59, Ext: +33, Email: philippe.remy@hmn.aph.fr

Henri Mondor Hospital, Creteil, Val de Marne 94010, France; Recruiting
Philippe REMY, MD, Phone: (0)1 49 81 24 59, Ext: +33, Email: philippe.remy@hmn.aph.fr

Starting date: October 2009
Last updated: December 27, 2011