Efficacy and Safety of Rituximab to That of Calcineurin Inhibitors in Children With Steroid Dependent Nephrotic Syndrome
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
Summary
Nephrotic syndrome in children is primarily caused by minimal change disease. Majority of
these patients respond well to corticosteroids. However, as many as 70% of children with
nephrotic syndrome experience at least one relapse, and 30% develop a more complicated course
with frequent relapses (FRNS)(≥2 relapses/ 6 months) with or without steroid dependency
(SDNS)(relapse during tapering or within 2 weeks after discontinuation of corticosteroids).
Repeated and prolonged courses of steroids in these children often result in long-term
complications. The goal of the treatment is to reduce the rate of relapses, the cumulative
dose of corticosteroids, and the incidence of serious complications. In order to minimize the
side effects of steroid therapy, different steroid sparing agents such as cyclophosphamide,
calcineurin inhibitors(CNI), levamisole, and mycophenolate mofetil (MMF) have been used in
SDNS. Whereas CNI are usually considered the steroid sparing drug class of first choice,
rituximab is increasingly used as alternative to minimize CNI toxicity. Various prospective
studies suggest that Rituximab, a B cell depleting monoclonal antibody, could be a safe and
effective alternative to steroid or immunosuppressants to achieve and maintain remission in
this population.Single rituximab course have been shown to be efficacious for 6 to 12 months
and the side effect profile observed to date is very benign. Studies comparing the usefulness
of these agents are lacking. In our proposed randomized controlled trial, the investigators
want to compare the efficacy and safety of CNI to that of Rituximab in treating children with
SDNS.