Efficacy and Safety of Rituximab to That of Calcineurin Inhibitors in Children With Steroid Resistant Nephrotic Syndrome
Status:
Recruiting
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
The vast majority of children with idiopathic nephrotic syndrome respond well to
corticosteroid treatment. However, as many as 20% experience a more complicated course with
steroid resistance (SRNS). Repeated and prolonged courses of steroids in these children often
result in long-term complications. The goal of 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 SRNS. 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. Rituximab infusion 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 this proposed randomized controlled trial, the
investigators want to compare the efficacy and safety of CNI to that of Rituximab in treating
children with SRNS.