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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01055964

Enrollment

Registered

2010-01-26

Start date

2008-09-30

Completion date

Unknown

Last updated

2015-05-27

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

Conditions

Pharmacokinetics, Tacrolimus

Brief summary

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

Interventions

DRUGTacrolimus

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

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