Rituximab Trial for Pediatric Nephrotic Syndrome — RTX2012  

Steroid Resistant Nephrotic Syndrome Clinical Trial

Official title: A Multi-center Randomized Controlled Trial of Rituximab for Refractory Nephrotic Syndrome in Children

Status Recruiting

Clinical Trial Summary

Anti-CD20 agent has been proposed as a rescue therapy for refractory nephrotic syndrome(NS) on the basis of favorable clinical observations. Yet the long-term effect on maintaining remission or the likelihood of becoming rituximab-dependent is unclear and the information on the safety profile of rituximab is limited. This trial was designed to investigate the safety and efficacy of Rituximab in children with refractory NS.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Steroid Dependent Nephrotic Syndrome
• Steroid Resistant Nephrotic Syndrome
• Syndrome

• NCT number: NCT01716442
• Study type: Interventional
• Source: Seoul National University Childrens Hospital
• Contact: Hee Gyung A. Kang, M.D., Ph.D.
• Phone: +82-2072-0658
• Email: kanghg1@gmail.com
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 2012
• Completion date: November 2013