Childhood Idiopathic Nephrotic Syndrome Clinical Trial
Official title:
A Prospective, Randomized, Double Blind, Placebo-controlled Phase II/III Study Evaluating the Efficacy of Rituximab in the Prevention of Relapse of Calcineurin Inhibitors Dependent Idiopathic Nephrotic Syndrome of Childhood
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.
After infusions of Rituximab or placebo, patients will be examined by their nephrologist on a monthly basis during five months. Follow up will be focused on proteinuria, albuminemia, lymphocyte phenotyping and Rituximab pharmacokinetics ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05627557 -
A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome
|
Phase 3 |