Kidney Transplantation, Liver Transplantation
Conditions
Keywords
tacrolimus, pharmacokinetics, gene polymorphism, clinical factors
Brief 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.
Interventions
OTHERClinical and genetic factors
Sponsors
National Taiwan University Hospital
Study design
Observational model
CASE_ONLY
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-normalized tacrolimus concentration | Within the first 6 months post-transplantation |
Countries
Taiwan
Contacts
Primary ContactFe-Lin Lin Wu
Outcome results
None listed