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Rituximab Trial for Pediatric Nephrotic Syndrome (RTX2012)

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ClinicalTrials.gov Identifier: NCT01716442
Recruitment Status : Unknown
Verified October 2012 by Hee Gyung Kang, Seoul National University Childrens Hospital.
Recruitment status was:  Recruiting
First Posted : October 29, 2012
Last Update Posted : October 29, 2012
Sponsor:
Information provided by (Responsible Party):

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: October 29, 2012
Last Verified: October 2012

Keywords provided by Hee Gyung Kang, Seoul National University Childrens Hospital:
rituximab
nephrotic
refractory

Additional relevant MeSH terms:
Syndrome
Nephrotic Syndrome
Nephrosis
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents