Dettagli per singolo studio

DEC-NET Serial number FR232

Published online	24/05/2004 16.39.00
Last updated	16/11/2006 11.40.17

Other protocol ID number	PO21005
Current trial status	Closed to recruitment of participants: follow-up continuing
Major Disease (ICD9 class)	NEPHROTIC SYNDROME NOS
Experimental drug
mycophenolate mofetil Treatment regimen (dosage and duration) 600 mg/m2/day during the first week followed by 1200 mg/m2/day in 2 or 3 divided doses
Gender	Both
Age (range)	1-16 years old
Eligibility criteria
Inclusion criteria
- Relapse under corticosteroid therapy - Two relapses or more under corticosteroid every other day - Low growth velocity - Overweight - Major adverse effect of corticosteroid therapy
Exclusion criteria
- Nephrose corticoresistance becoming corticosensitive under cyclosporine - Girls likely to start pregnancy
Trial design/methodology
Phase	2
Kind of study	Efficacy Pharmacokinetics
Design	open
Purpose of study
To study the efficacy and pharmacokinetics of mycophenolate mofetil (MMF) in children with corticoid-dependent nephrotic syndrome, not improved by cyclophosphamide.




Summary of study design, objectives, and ongoing research findings
The aim of this project is to study the efficacy and pharmacokinetics of mycophenolate mofetil (MMF) in children with corticoid-dependent nephrosis, not improved by cyclophosphamide. The associated corticotherapy is reduced in a similar manner in all patients. MMF is prescribed at the dose 1200mg/m2/day in 2 divided doses. A pharmacokinetic study is performed at the end of the first month and during the fifth or sixth month. Patients re followed 1 year. The primary outcome is relapse during the first 6 months (failure of treatment and discontinuation).