NCT01716442

Rituximab Trial for Pediatric Nephrotic Syndrome

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Seoul National University Childrens Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Steroid Resistant Nephrotic Syndrome
• Steroid Dependent Nephrotic Syndrome

Interventions

Type	Name	Description
DRUG	Rituximab	Per dose: Rituximab 375 mg/m2 (max.500mg/day). efficacy monitored by CD19 cell count. If CD19 cells are not depleted, second or third doses are given at 2-3 weeks interval.
DRUG	Placebo

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-09-01
• Completion: 2013-11-01
• First posted: 2012-10-29
• Last updated: 2012-10-29

Locations

1 site across 1 country: South Korea