NCT01895894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

3.3 years

First QC Date

July 7, 2013

Last Update Submit

July 4, 2017

Conditions

Nephrotic Syndrome

Keywords

Mycophenolate mofetilImmunosuppressive AgentsNephrosis

Outcome Measures

Primary Outcomes (1)

  • relapse free time

    1 year

Secondary Outcomes (1)

  • adverse effect

    1 year

Study Arms (2)

Mycophenolate mofetil

EXPERIMENTAL
Drug: Mycophenolate mofetil

Control

NO INTERVENTION

Interventions

Mycophenolate mofetilDRUG

Mycophenolate mofetil 20\~30mg/kg/day PO until nephrotic syndrome relapse (max. 1 year)

Also known as: Myrept capsule/tablet
Mycophenolate mofetil

Eligibility Criteria

Age2 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Children's Hospital

Seoul, 110-740, South Korea

Location

Related Publications (1)

  • Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.

    PMID: 39513526DERIVED

MeSH Terms

Conditions

Nephrotic SyndromeNephrosis

Interventions

Mycophenolic AcidTablets

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsDosage FormsPharmaceutical Preparations

Study Officials

  • Hee Gyung Aurea Kang, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 7, 2013

First Posted

July 11, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 6, 2017

Record last verified: 2017-07

Locations

KR(1)