Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome

July 4, 2017 updated by: Hee Gyung Kang, Seoul National University Hospital

A Prospective, Randomized, Open-label Study Evaluating the Efficacy of Mycophenolate Mofetil in the Prevention of Relapse of Steroid Dependent Nephrotic Syndrome in Children

Idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients need other immunosuppressants to reduce steroid dependency. The long-term use should be restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity.

Mycophenolate mofetil for steroid-dependent nephrotic syndrome has been reported to have similar efficacy and fewer undesirable effects to other drugs in mainly observational studies. To determine the efficacy of mycophenolate mofetil in the management of steroid-dependent nephrotic syndrome, the investigators designed this prospective randomized controlled study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-740
        • Seoul National University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Steroid-dependent patients who had been on calcineurin inhibitors continuously for more than 1 year
  • in complete remission

Exclusion Criteria:

  • Hereditary or secondary nephrotic syndrome
  • Estimated glomerular filtration rate (GFR) < 60 mg/min/1.73 m^2
  • Body weight <16 kg
  • leukocytopenia (absolute neutrophil count < 2000/mm^3) or anemia(Hct < 25%)
  • Severe gastrointestinal disease
  • chronic or acute active infection (e.g. hepatitis B,C, herpes, varicella zoster)
  • prior live vaccine inoculation within 6 weeks (from the study enrollment)
  • GOT/GPT elevation or hyperbilirubinemia
  • malignant disease
  • Pregnant or Breast feeding
  • Previous history of mycophenolate mofetil use
  • Participation to other therapeutic trial within recent 3 months
  • Deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Mycophenolate mofetil
Drug: Mycophenolate mofetil
Mycophenolate mofetil 20~30mg/kg/day PO until nephrotic syndrome relapse (max. 1 year)
Other Names:
  • Myrept capsule/tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
relapse free time
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse effect
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Hee Gyung Aurea Kang, M.D., Ph.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 7, 2013

First Submitted That Met QC Criteria

July 7, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 4, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMF2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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