The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism and Other Factors on Tacrolimus Blood Concentration

National Taiwan University

Status: Unknown

Conditions: Liver Transplantation; Kidney Transplantation

Treatments: Other: Clinical and genetic factors

Study type: Observational

Funder types: Other

Identifiers

NCT02707822

201512005RINC

Details and patient eligibility

About

The purpose of the study is to identify factors that may influence tacrolimus (TAC) pharmacokinetics, and the impact of gene polymorphism (ABCB1, CYP3A4, CYP3A5, POR) on pharmacokinetics of TAC in Taiwanese.

Full description

TAC is one of the most important immunosuppressive agents for organ transplantation. In some patients the dose and concentration of TAC are difficult to adjust because of its narrow therapeutic index and variable pharmacokinetics.

Many factors affect the pharmacokinetics of TAC. Literature suggests that ABCB1, CYP3A4, CYP3A5, POR gene polymorphisms may affect the pharmacokinetics of TAC. In addition, the distribution of TAC is affected by hematocrit and albumin concentrations. The pharmacokinetics of TAC may also be affected by total protein, total bilirubin, creatinine, AST, ALT, gender, age, drug interactions, and so on.

This study intends to analyze the influence of various factors, including drugs, on the pharmacokinetics of TAC.

Enrollment: 440 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• kidney transplants or liver transplants
• 20 - 65 years old
• receiving tacrolimus as immunosuppressive drugs

Exclusion criteria

• Human immunodeficiency virus-positive status
• Retransplantation or multiorgan transplantation
• non-Asian

Trial design

440 participants in 1 patient group

kidney or liver transplantation

Description:

Renal or liver transplant recipients with tacrolimus as immunosuppressive drugs.

Treatment:

Other: Clinical and genetic factors