Impact of POR*28 and CYP3A5 polymorphisms on trough concentration to dose ratio of tacrolimus in Thai kidney transplant recipients

Not Applicable

Completed

• Conditions: kidney transplantation; CYP3A5, kidney transplant, pharmacokinetic, pharmacogenetic, POR*28, tacrolimus

• Registration Number: TCTR20170227005
• Lead Sponsor: Assoc. Prof. Dr. Atiporn Ingsathit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-27
• Study Completion: 2018-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Eligible patients are those who received tacrolimus for at least 3 months after their kidney transplantation together with mycophenolate mofetil or mycophenolate sodium.

Exclusion Criteria

1) Multi-organ transplantation
2) Hyper-acute graft rejection
3) History of cirrhosis, hepatocelluar carcinoma or hepatitis
4) Severely impaired liver function
5) Hypoalbuminemia (serum albumin <3g/dl)
6) Receiving co-medications that interfere the pharmacokinetic of tacrolimus except for methylprednisolone, prednisolone, and omeprazole

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
trough concentration to dose ratio of tacrolimus blood concentrations Days 3, 7, 90, 180 after transplantation immunoassay

Secondary Outcome Measures

Name	Time	Method
tacrolimus trough concentrations Days 3, 7, 90, 180 immunoassay