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

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

Study Overview

• Status: Completed
• Conditions: Liver Transplantation

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 Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan, 10050
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

liver transplant patients' donors

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
liver transplant patients and donors; To study clinical and genetic factors on tacrolimus dose normalized trough concentration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose normalized trough concentration of tacrolimus in liver transplant patients 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.	Within the first 6 months post-transplantation

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Rey-Heng Hu, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 21, 2017
• Primary Completion (ACTUAL): April 12, 2018
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (ACTUAL): May 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Tacrolimus; Genetic polymorphisms
• Other Study ID Numbers: 201612023RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No