NCT02707822

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 440 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Kidney Transplantation
• Liver Transplantation

Interventions

Type	Name	Description
OTHER	Clinical and genetic factors

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-03-14
• Last updated: 2016-03-14

Locations

1 site across 1 country: Taiwan