Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01895894

Enrollment

Registered

2013-07-11

Start date

2013-09-30

Completion date

2016-12-31

Last updated

2017-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrotic Syndrome

Keywords

Mycophenolate mofetil, Immunosuppressive Agents, Nephrosis

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.

Interventions

DRUGMycophenolate mofetil

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 24 Years

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

Design outcomes

Primary

Measure	Time frame
relapse free time	1 year

Secondary

Measure	Time frame
adverse effect	1 year

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026