Rituximab Trial for Pediatric Nephrotic Syndrome (RTX2012)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Seoul National University Childrens Hospital
Sponsor:
Information provided by (Responsible Party):
Hee Gyung Kang, Seoul National University Childrens Hospital
ClinicalTrials.gov Identifier:
NCT01716442
First received: October 25, 2012
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Steroid Resistant Nephrotic Syndrome
Steroid Dependent Nephrotic Syndrome
Drug: Rituximab
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Multi-center Randomized Controlled Trial of Rituximab for Refractory Nephrotic Syndrome in Children

Resource links provided by NLM:


Further study details as provided by Seoul National University Childrens Hospital:

Primary Outcome Measures:
  • The remission rate of steroid-resistant nephrotic syndrome patients after rituximab treatment [ Time Frame: within 6 months from the initiation of treatment ] [ Designated as safety issue: No ]
  • The rate of maintaining remission in steroid-dependent nephrotic syndrome patients [ Time Frame: within 6 months from the initiation of treatment versus placebo control ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: August 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716442

Contacts
Contact: Hee Gyung A. Kang, M.D., Ph.D. +82-2072-0658 kanghg1@gmail.com

Locations
Korea, Republic of
Seoul National University Children's Hospital Recruiting
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
  More Information

No publications provided

Responsible Party: Hee Gyung Kang, Associate Professor, Seoul National University Childrens Hospital
ClinicalTrials.gov Identifier: NCT01716442     History of Changes
Other Study ID Numbers: RTX-2012
Study First Received: October 25, 2012
Last Updated: October 26, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Childrens Hospital:
rituximab
nephrotic
refractory

Additional relevant MeSH terms:
Nephrotic Syndrome
Nephrosis
Kidney Diseases
Urologic Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014