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Completed

NCT Number: NCT01084980

Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome

The hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with minimal change nephritic syndrome.

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Key information

Conditions

Minimal Change Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Nephrosis, Lipoid Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

A pilot study for comparative clinical trial on the therapeutic effect of tacrolimus (Prograf cap®) in adult patient with minimal change nephritic syndrome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • from 18yrs to 80 yrs , man and women
  • Minimal change disease is diagnosed by kidney biopsy
  • On screening, the patient shows that the level of urine protein/creatinine ratio is over 3.0
  • On screening, the patient shows that the serum albumin is below 3.0g/dL
  • the patient sign on the concent form

Exclusion criteria

  • the patient have experience to take tacrolimus or cyclosporin for 1 month
  • If it is the relapse of the nephrotic syndrome, before relapse, the maintenance dose of steroid is over 0.3 mg/kg/day
  • steroid dependent or steroid resistant or frequent relapse case
  • uncontrolled hypertension
  • pregnancy or anticipate pregnancy with 6 month
  • hypersensitivity to tacrolimus or macrolide
  • acute hepatitis or the level of AST or ALT is over 2 times of normal range or the level of bilirubin is over 2.0 mg/dL

Treatment and study plan

Tacrolimus

Drug

tacrolimus 0.05mg/kg bid for 12 weeks corticosteroid 0.3 - 0.5mg/kg qd

Other names: Prograf

Primary outcomes

  1. remission of proteinuria

    Time frame: 12 weeks

Secondary outcomes

  1. time to remission, relapse rate, response failure rate

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Pilot Study for Comparative Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap®) in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome

Acronym: MCNS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 11, 2010
Registry last updated
Aug 16, 2011

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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