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.

ABSTRACT:

Introduction

Rituximab (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 pat

SUBMITTER: Liu J 

PROVIDER: S-EPMC9562314 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature