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Completed

NCT Number: NCT01476488

Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable pediatric kidney transplant recipients.

Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and after that, the same dose of advagraf will be prescribed. The patients will have another pharmacokinetic study of tacrolimus after conversion to advagraf.

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Key information

Conditions

Kidney Transplantation Maintenance With Tacrolimus Pediatric Patients

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ABO-compatible kidney-only transplantation
  • more than 1 year after kidney transplantation
  • 5 to 15 years old
  • patients maintained on Prograf
  • tacrolimus level of determined previously: 4 to 20 ng/ml
  • eGFR by Schwartz equation > 50mL/min

Exclusion criteria

  • patients with acute rejection within 90 days
  • patients with acute rejection requiring antibody therapy within 6 months
  • patients with more than 2 times of acute rejection within 1 year
  • AST/ALT 2 times more than upper normal limit
  • ABO-incompatible or crossmatch-positive transplantation
  • multiorgan transplantation

Treatment and study plan

Tacrolimus

Drug

Other names: Prograf, Advagraf

Primary outcomes

  1. Area Under the Curve of tacrolimus pharmacokinetics (AUC0-24)

    The investigator will compare the changes in AUC0-24 of tacrolimus, Cmax, Tmax and correlation between C0 and Cmax

Secondary outcomes

  1. Number of Participants with Adverse Event

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Conversion of Twice-a-day Tacrolimus to Once-Daily Tacrolimus Extended-Release Formulation in Stable Pediatric Kidney Transplant Recipients

Important dates

Study start
2011
Primary completion
2013
First posted
Nov 22, 2011
Registry last updated
May 27, 2015

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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