Rituximab Trial for Pediatric Nephrotic Syndrome

Sponsor
Seoul National University Childrens Hospital
Study ID
NCT01716442
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Steroid Dependent Nephrotic Syndrome
  • Steroid Resistant Nephrotic Syndrome

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    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.
  • Placebo — DRUG

Study Details

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.

Key Dates

Start date
Aug 31, 2012
Status verified
Oct 2012
Primary completion
Sep 30, 2013
Completion
Nov 30, 2013

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: steroid-resistant
    Steroid-resistant group: n=27 , enroll all for treatment
  • Active Comparator: steroid-dependent-rituximab
    steroid-responsive group: n=38
  • Placebo Comparator: steroid-dependent-placebo
    steroid-responsive group: n=23

Primary Outcome Measure

The remission rate of steroid-resistant nephrotic syndrome patients after rituximab treatment [ Time Frame: within 6 months from the initiation of treatment ]

Central Contacts