Rituximab Trial for Pediatric Nephrotic Syndrome

Steroid Resistant Nephrotic Syndrome Clinical Trial

— RTX2012  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01716442
• Other study ID #: RTX-2012
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 25, 2012
• Last updated: October 26, 2012
• Start date: August 2012
• Est. completion date: November 2013

Study information

• Verified date: October 2012
• Source: Seoul National University Childrens Hospital
• Contact: Hee Gyung A. Kang, M.D., Ph.D.
• Phone: +82-2072-0658
• Email: kanghg1[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

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

Intervention

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.
• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Childrens Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The remission rate of steroid-resistant nephrotic syndrome patients after rituximab treatment		within 6 months from the initiation of treatment	No
Primary	The rate of maintaining remission in steroid-dependent nephrotic syndrome patients		within 6 months from the initiation of treatment versus placebo control	No