Idiopathic Nephrotic Syndrome Clinical Trial
Official title:
Cyclophosphamide Versus Mycophenolate Mofetil for Children With Steroid-dependent Idiopathic Nephrotic Syndrome : a Multicenter Randomized Controlled Trial
Idiopathic nephrotic syndrome is steroid-sensitive in more than 90% of cases in children.
However 60% of cases are steroid dependent and required treatment with immunosuppressive
agent. Cyclophosphamide and ciclosporin are used for long time to reduce steroid dependency,
but duration of these treatments should be restricted because of gonadotoxicity for
cyclophosphamide and nephrotoxicity for ciclosporin.
Mycophenolate mofetil appears as an alternative treatment without gonadotoxicity and
nephrotoxicity. However, contrary to cyclophosphamide, mycophenolate mofetil does not seem
to have a residual action so that treatment must be maintained during months or years.
The aim of the study is to compare efficacy of cyclophosphamide and mycophenolate mofetil in
steroid dependent nephrotic syndrome in children.
Aim of the study: Comparison of efficacy of cyclophosphamide 148mg/kg in 12 weeks and
mycophenolate mofetil 1200mg/m² during 18 months, in children with steroid dependent
nephrotic syndrome.
The 70 patients will be recruited in the 26 centres of paediatric nephrology in France,
included and randomized at the time of a relapse. They will receive the same steroid
treatment in the 2 arms.
The primary point will be occurrence of a relapse during the 24 months of follow-up.
Detection of relapse will be done by using dipsticks and confirm by biological dosages
(albuminemia and proteinuria/CREATININURIA ratio). Clinical and biological check up will be
done every 3 months during all the study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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