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RTX2012: Rituximab Trial for Pediatric Nephrotic Syndrome

Sponsor
Seoul National University Childrens Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01716442
Collaborator
(none)
88
Enrollment
1
Location
3
Arms
15
Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Multi-center Randomized Controlled Trial of Rituximab for Refractory Nephrotic Syndrome in Children
Study Start Date :
Aug 1, 2012
Anticipated Primary Completion Date :
Sep 1, 2013
Anticipated Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: steroid-resistant

Steroid-resistant group: n=27 , enroll all for treatment

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.
Other Names:
  • Mabthera
  • 2005110300291 (rituximab)

    		•
    Active Comparator: steroid-dependent-rituximab

    steroid-responsive group: n=38

    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.
    Other Names:
  • Mabthera
  • 2005110300291 (rituximab)

    		•
    Placebo Comparator: steroid-dependent-placebo

    steroid-responsive group: n=23

    Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

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

    2. The rate of maintaining remission in steroid-dependent nephrotic syndrome patients [within 6 months from the initiation of treatment versus placebo control]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Children's Hospital Seoul Korea, Republic of 110-740

    Sponsors and Collaborators

    • Seoul National University Childrens Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hee Gyung Kang, Associate Professor, Seoul National University Childrens Hospital
    ClinicalTrials.gov Identifier:
    NCT01716442
    Other Study ID Numbers:
    • RTX-2012
    First Posted:
    Oct 29, 2012
    Last Update Posted:
    Oct 29, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by Hee Gyung Kang, Associate Professor, Seoul National University Childrens Hospital
    rituximab
    nephrotic
    refractory
    Additional relevant MeSH terms:
    Nephrotic Syndrome
    Nephrosis
    Syndrome
    Rituximab

    Study Results

    No Results Posted as of Oct 29, 2012