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

Seoul National University Hospital80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Pharmacokinetics Tacrolimus

Interventions

TacrolimusDRUG

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

pharmacokinetics

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

Data from ClinicalTrials.gov

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