Efficacy of Rituximab For the Treatment of Calcineurin Inhibitors Dependent Nephrotic Syndrome During Childhood
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
Background
Idiopathic nephrotic syndrome is a rare disease beginning during childhood and treated with
immunosuppressants (i.e. steroids, mycophenolate mofetil, cyclophosphamide, cyclosporine).
Renal function of patients suffering from severe, steroid-dependent nephrotic syndrome with
failure or toxic side effects of other immunosuppressant treatments is a major matter of
concern.
Cyclosporine endangers renal parenchyma (fibrosis) in these patients who must take this
treatment for years. At the same time, low doses of cyclosporine allow proteinuria to
reappear, which provokes degradation of renal function by focal segmental glomerulosclerosis.
Some recent data lead to the conclusion that Rituximab may be effective in such a disease,
with a cyclosporin sparing effect.
Purpose
The aim of the study is to evaluate the efficacy of Rituximab versus placebo in the treatment
of pediatric patients suffering from severe cyclosporine-dependent nephrotic syndrome.
Abstract Patients will be included in the study in a period of remission of proteinuria. Two
infusions of Rituximab - at the dose of 375 mg/m²- or placebo will be administered at one
week of interval. Other immunosuppressant treatments will be gradually tapered off with the
same tapering pattern in both groups. In case of relapse of nephrotic syndrome, the blinding
code will be broken. Rituximab will then be infused to patients having received placebo.