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

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

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Key information

Conditions

Liver Transplantation

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital, Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

Dose normalized trough concentration of tacrolimus in liver transplant patients within the first 6 months post-transplantation

Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2020
First posted: May 4, 2017
Registry last updated: Aug 11, 2021

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