Rituximab Trial for Pediatric Nephrotic Syndrome

Phase 2

• Conditions: Steroid Resistant Nephrotic Syndrome; Steroid Dependent Nephrotic Syndrome
• Interventions: Drug: Rituximab; Drug: Placebo

• Registration Number: NCT01716442
• Lead Sponsor: Seoul National University Childrens Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Status Verified: 2012-10
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-10-26
• Last Update Submitted: 2012-10-26
• Study First Posted: 2012-10-29
• Last Update Posted: 2012-10-29
• Primary Completion: 2013-09
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

(A)steroid/calcineurin inhibitor resistant nephrotic syndrome

1. steroid resistance: no remission after 4 weeks of daily oral corticosteroid (60mg/m2/day)
2. calcineurin inhibitor resistance: no remission after 3 months of therapeutic dose administration of cyclosporine and/or tacrolimus
3. no remission defined by persistent proteinuria of nephrotic range for the last 3 months
4. post-transplant patients were included in the study

(B)steroid-dependent nephrotic syndrome

1. Steroid-dependent patients who had been on various known medications (such as corticosteroids, cyclophosphamide, chlorambucil, calcineurin inhibitors, levamisole ..) continuously for more than 2 years

2. definition of dependency: more than two consecutive relapse events in 2 weeks after discontinuation of steroid or calcineurin inhibitor

   • no improvement in relapsing frequency with calcineurin inhibitor use
   • unable to continue with calcineurin inhibitor due to side effects
   • unable to continue with calcineurin inhibitor due to prolonged use (over 2 years)
   • other conditions in which the clinician considers difficult to control disease with steroids or calcineurin inhibitors only.

Exclusion Criteria

• previous rituximab use
• secondary nephrotic syndrome
• estimated GFR <60mL/min/1.73m2 or under 50% of age-matched standard GFR
• chronic or acute active infection (e.g. hepatitis B,C, herpes, varicella zoster)
• prior live vaccine inoculation within 1 month (from the study enrollment)
• cardiovascular diseases, pulmonary or pleural diseases
• uncontrolled hypertension
• leukocytopenia (absolute neutrophil count <1500/mm3) or thrombocytopenia (<75000/mm3)
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
steroid-resistant	Rituximab	Steroid-resistant group: n=27 , enroll all for treatment
steroid-dependent-rituximab	Rituximab	steroid-responsive group: n=38
steroid-dependent-placebo	Placebo	steroid-responsive group: n=23

Primary Outcome Measures

Name	Time	Method
The remission rate of steroid-resistant nephrotic syndrome patients after rituximab treatment	within 6 months from the initiation of treatment
The rate of maintaining remission in steroid-dependent nephrotic syndrome patients	within 6 months from the initiation of treatment versus placebo control

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of