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Rituximab Trial for Pediatric Nephrotic Syndrome (RTX2012)

Primary Purpose

Steroid Resistant Nephrotic Syndrome, Steroid Dependent Nephrotic Syndrome

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rituximab
Placebo
Sponsored by
Seoul National University Childrens Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Steroid Resistant Nephrotic Syndrome focused on measuring rituximab, nephrotic, refractory

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

steroid-resistant

steroid-dependent-rituximab

steroid-dependent-placebo

Arm Description

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

steroid-responsive group: n=38

steroid-responsive group: n=23

Outcomes

Primary Outcome Measures

The remission rate of steroid-resistant nephrotic syndrome patients after rituximab treatment
The rate of maintaining remission in steroid-dependent nephrotic syndrome patients

Secondary Outcome Measures

Full Information

First Posted
October 25, 2012
Last Updated
October 26, 2012
Sponsor
Seoul National University Childrens Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01716442
Brief Title
Rituximab Trial for Pediatric Nephrotic Syndrome
Acronym
RTX2012
Official Title
A Multi-center Randomized Controlled Trial of Rituximab for Refractory Nephrotic Syndrome in Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Childrens Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Steroid Resistant Nephrotic Syndrome, Steroid Dependent Nephrotic Syndrome
Keywords
rituximab, nephrotic, refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
steroid-resistant
Arm Type
Active Comparator
Arm Description
Steroid-resistant group: n=27 , enroll all for treatment
Arm Title
steroid-dependent-rituximab
Arm Type
Active Comparator
Arm Description
steroid-responsive group: n=38
Arm Title
steroid-dependent-placebo
Arm Type
Placebo Comparator
Arm Description
steroid-responsive group: n=23
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Mabthera, 2005110300291 (rituximab)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The remission rate of steroid-resistant nephrotic syndrome patients after rituximab treatment
Time Frame
within 6 months from the initiation of treatment
Title
The rate of maintaining remission in steroid-dependent nephrotic syndrome patients
Time Frame
within 6 months from the initiation of treatment versus placebo control

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (A)steroid/calcineurin inhibitor resistant nephrotic syndrome steroid resistance: no remission after 4 weeks of daily oral corticosteroid (60mg/m2/day) calcineurin inhibitor resistance: no remission after 3 months of therapeutic dose administration of cyclosporine and/or tacrolimus no remission defined by persistent proteinuria of nephrotic range for the last 3 months post-transplant patients were included in the study (B)steroid-dependent nephrotic syndrome Steroid-dependent patients who had been on various known medications (such as corticosteroids, cyclophosphamide, chlorambucil, calcineurin inhibitors, levamisole ..) continuously for more than 2 years 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Gyung A. Kang, M.D., Ph.D.
Phone
+82-2072-0658
Email
kanghg1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Gyung Kang A. Kang, M.D., Ph.D.
Organizational Affiliation
Seoul National University Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Children's Hospital
City
Seoul
ZIP/Postal Code
110-740
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Rituximab Trial for Pediatric Nephrotic Syndrome

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