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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nephrotic Syndrome

Intervention / Treatment
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* Drug: Prednisone
* Drug: acid mycophenolic (Myfortic)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B-Experimental<br>Experimental | Drug: acid mycophenolic (Myfortic)<br>* 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<br>* Other names: Bitherapy: Association of low dose corticosteroids 0.5 mg/kg/day and Myfortic ® at a dose of 1440 mg/day.;|
| Active Comparator: A-Active Comparator<br>Active Comparator | Drug: Prednisone<br>* 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.<br>* Other names: Monotherapy: treatment with only corticosteroids at doses usually 1 mg/kg/day,following a plan of reduction based on the degree of remission.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission | complete remission | within 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission | complete remission | within 8 weeks | 
| partial remission | partial remission | within 4 and 8 weeks | 
| Adverse effects in both arms | Adverse effects in both arms | 1 year | 
| Number of flare in both arms | Number of flare in both arms | at 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimal Change Nephrotic Syndrome, Complete remission, Myfortic, Minimal Change Disease