Protocol for an open-label, single-arm, multicentre clinical study to evaluate the efficacy and safety of rituximab in the first episode of paediatric idiopathic nephrotic syndrome.

introductionRituximab (RTX) effectively prevents relapses in patients with complicated steroid-sensitive nephrotic syndrome (SSNS). The 1-year relapse-free survival rate is approximately 30% in children after the first episode of SSNS treated with standardised corticosteroids. Whether the benefits of RTX extend to the first relapse are unknown. The efficacy and safety of RTX in the first episode of paediatric idiopathic nephrotic syndrome (RTXFIRPedINS) trial (NCT04783675) will assess its effect on the risk of subsequent relapse. METHODS AND ANALYSIS: RTXFIRPedINS is an open-label, single-arm, multicentre trial targeting patients aged 1-18 years with a first episode of SSNS. All patients will receive standardised corticosteroid treatment for 12 weeks. A sample size of 44 patients provides 80% power to detect a 20% increase in the 1-year relapse-free rate, assuming a dropout rate of 10%. After obtaining informed consent and screening, eligible patients will be treated with a single intravenous infusion of 375 mg/m ETHICS AND DISSEMINATION: This trial was approved by the Ethics Committee of the Children's Hospital of Fudan University and seven local ethics committees. We will publish our study results in peer-reviewed journals and present them at international scientific meetings. TRIAL REGISTRATION NUMBER: NCT04783675.