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Rituximab Trial for Pediatric Nephrotic Syndrome

NCT01716442 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2012-10-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Seoul National University Childrens Hospital

    lead OTHER

Principal Investigators

  • Hee Gyung Kang A. Kang, M.D., Ph.D. · Seoul National University Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-09-30
Completion
2013-11-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01716442 on ClinicalTrials.gov