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

Completed

• Conditions: Liver Transplantation

• Registration Number: NCT03140462
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-04
• Study Start: 2017-05-21
• Primary Completion: 2018-04-12
• Status Verified: 2020-12
• Study Completion: 2020-12-31
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan