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OpenTrials
Completed

NCT Number: NCT01895894

Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome

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.

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Key information

Conditions

Nephrotic Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Urogenital Diseases Urologic Diseases

Age range

2 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Children's Hospital

Seoul, 110-740, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mycophenolate mofetil

Drug

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

Other names: Myrept capsule/tablet

Primary outcomes

  1. relapse free time

    Time frame: 1 year

Secondary outcomes

  1. adverse effect

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Chong Kun Dang Pharmaceutical

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2013
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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