Study of Rituximab Monotherapy Versus Steroid Therapy in Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial

What this Trial Is About

This research aims to evaluate the effectiveness of Rituximab monotherapy compared to steroid therapy in children with new-onset nephrotic syndrome. Nephrotic syndrome is the most common glomerular disease in children, and although steroids have been the main treatment for decades, they can cause side effects such as impaired growth, increased fat, and glaucoma. The study addresses the need for steroid-sparing treatments and explores Rituximab, an antibody targeting CD20, which has shown promise in certain patients but remains unclear in children with new-onset nephrotic syndrome. Participants are randomly assigned to one of two groups. The Rituximab group receives four doses of 375 mg/m2 Rituximab at one-week intervals, along with trimethoprim-sulfamethoxazole for three months to prevent infections. The steroid group receives daily oral prednisone or prednisolone at 2 mg/kg/day (up to 60 mg) for six weeks, followed by alternate-day doses at 1.5 mg/kg (up to 50 mg) for another six weeks, with vitamin D and calcium supplements for three months. Four doses of Rituximab are given regardless of remission status. During the 52-week follow-up, participants undergo regular assessments including monitoring for recurrence-free survival from first remission, time to remission, relapse rates, and cumulative steroid dosage. Researchers will also evaluate complete remission and treatment inefficiency within the first six weeks. Safety and disease progression are closely monitored through clinical evaluations. The total study duration covers admission through 52 weeks post-remission to understand long-term outcomes.

Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial