Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome (MSN)
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|ClinicalTrials.gov Identifier: NCT01197040|
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : June 28, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Nephrotic Syndrome||Drug: Prednisone Drug: acid mycophenolic (Myfortic)||Phase 3|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||117 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Low Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||June 2015|
Drug: acid mycophenolic (Myfortic)
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
Other Name: 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
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.
Other Name: Monotherapy: treatment with only corticosteroids at doses usually 1 mg/kg/day,following a plan of reduction based on the degree of remission.
- complete remission [ Time Frame: within 4 weeks ]complete remission
- complete remission [ Time Frame: within 8 weeks ]complete remission
- partial remission [ Time Frame: within 4 and 8 weeks ]partial remission
- Adverse effects in both arms [ Time Frame: 1 year ]Adverse effects in both arms
- Number of flare in both arms [ Time Frame: at 1 year ]Number of flare in both arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197040
|Henri Mondor Hospital|
|Creteil, Val de Marne, France, 94010|
|Principal Investigator:||Philippe REMY, MD||Assistance Publique - Hôpitaux de Paris|