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Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome

Primary Purpose

Nephrotic Syndrome

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mycophenolate mofetil
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrotic Syndrome focused on measuring Mycophenolate mofetil, Immunosuppressive Agents, Nephrosis

Eligibility Criteria

2 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mycophenolate mofetil

Control

Arm Description

Outcomes

Primary Outcome Measures

relapse free time

Secondary Outcome Measures

adverse effect

Full Information

First Posted
July 7, 2013
Last Updated
July 4, 2017
Sponsor
Seoul National University Hospital
Collaborators
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01895894
Brief Title
Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome
Official Title
A Prospective, Randomized, Open-label Study Evaluating the Efficacy of Mycophenolate Mofetil in the Prevention of Relapse of Steroid Dependent Nephrotic Syndrome in Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrotic Syndrome
Keywords
Mycophenolate mofetil, Immunosuppressive Agents, Nephrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mycophenolate mofetil
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Other Intervention Name(s)
Myrept capsule/tablet
Intervention Description
Mycophenolate mofetil 20~30mg/kg/day PO until nephrotic syndrome relapse (max. 1 year)
Primary Outcome Measure Information:
Title
relapse free time
Time Frame
1 year
Secondary Outcome Measure Information:
Title
adverse effect
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Gyung Aurea Kang, M.D., Ph.D.
Organizational Affiliation
Seoul National University 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

12. IPD Sharing Statement

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Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome

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