Influence of Genetic Polymorphism of Donor on Tacrolimus Concentration in Liver Transplant

The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism of Donor on Tacrolimus Blood Concentration in Liver Transplant Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03140462

Enrollment

Registered

2017-05-04

Start date

2017-05-21

Completion date

2020-12-31

Last updated

2021-08-11

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

Conditions

Liver Transplantation

Keywords

Tacrolimus, Pharmacokinetics, Genetic polymorphisms

Brief summary

To study the influence of donor's ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on tacrolimus blood concentration in liver transplant recipients.

Detailed description

This study will start with a retrospective data analysis. The investigators will use the electronic databases of National Taiwan University Hospital to identify patients who underwent liver transplantation, received tacrolimus and were still followed up at the outpatient clinic. Inclusion and exclusion criteria will be applied to screen appropriate participants, and find their donors. And analyze the effect of genetic polymorphism (ABCB1、CYP3A4、CYP3A5、POR) of donors, including other factors of recipients, on the dose normalized trough concentration of tacrolimus.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Inclusion criteria

donors' recipients * Living liver transplant during 20070101 \ 20151231 and only received liver transplantation * Lab data at least 8 months, * Receiving tacrolimus as immunosuppressive drugs * Transplantation at 20 \ 65 years old

Exclusion criteria

donors' recipients * Retransplantation or multi-organ transplantation * Non-Asian * Positive for human immunodeficiency virus.

Design outcomes

Primary

Measure	Time frame	Description
Dose normalized trough concentration of tacrolimus in liver transplant patients within the first 6 months post-transplantation	Within the first 6 months post-transplantation	Analyse the effect of the donor's genetic polymorphism to dose normalized trough concentration of tacrolimus in liver transplant patients. Trough level of tacrolimus was adjusted by liver recipient's body weight.

Countries

Taiwan

Outcome results