Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01197040 | Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome | PHASE3 | COMPLETED | 117 | — | — | Oct 1, 2009 | Jun 1, 2015 | Jun 28, 2017 | 1 | France |
| Arm | Type | Description |
|---|---|---|
| B-Experimental | EXPERIMENTAL | Experimental |
| A-Active Comparator | ACTIVE_COMPARATOR | Active Comparator |
| Name | Type | Description |
|---|---|---|
| Prednisone | DRUG | 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. |
| acid mycophenolic (Myfortic) | DRUG | 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 |
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...