Nephrotic Syndrome
Conditions
Keywords
Minimal Change Nephrotic Syndrome, Complete remission, Myfortic, Minimal Change Disease
Brief 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
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. 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.
Interventions
DRUGPrednisone
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.
DRUGacid 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
Sponsors
Novartis
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete remission | within 4 weeks | complete remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complete remission | within 8 weeks | complete remission |
| partial remission | within 4 and 8 weeks | partial remission |
| Adverse effects in both arms | 1 year | Adverse effects in both arms |
| Number of flare in both arms | at 1 year | Number of flare in both arms |
Countries
France
Outcome results
None listed