Status:
COMPLETED
Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Novartis
Conditions:
Nephrotic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 wit...
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 complication...
Eligibility Criteria
Inclusion
- Idiopathic nephrotic syndrome
- Flare of idiopathic syndrome without treatment from one year
- Confirming by Renal Biopsy
Exclusion
- Secondary nephrotic syndrome
- Pregnancy
- Focal Segmental Glomerular sclerosis lesion in the Biopsy
- Neutropenia \< 2000/mm3
- Hb\<9gr/dl
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT01197040
Start Date
October 1 2009
End Date
June 1 2015
Last Update
June 28 2017
Active Locations (1)
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1
Henri Mondor Hospital
Créteil, Val de Marne, France, 94010