a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients

The aim of this study is to identify the pharmacokinetic differences between two oral forms of Tacrolimus and consequent nephrotoxicity.

Completed

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Key information

Conditions

Pharmacokinetics Tacrolimus

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

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

Inclusion criteria

ABO-compatible renal transplant recipients

Exclusion criteria

multi-organ transplant
HIV(+) donor or recipients
history of malignancy other than skin cancer (except completely cured basal cell ca or squamous cell ca)
more than three-fold increase in AST or ALT level for 28 days
pregnancy
lactation

Treatment and study plan

Tacrolimus

Drug

Primary outcomes

pharmacokinetics

Time frame: at postoperative 10~14 days and at postoperative 6 months for crossover study

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2014
First posted: Jan 26, 2010
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.

Published trials that share one or more normalized conditions with this study.

Completed