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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| kidney or liver transplantation | Renal or liver transplant recipients with tacrolimus as immunosuppressive drugs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical and genetic factors | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-normalized tacrolimus concentration | Within the first 6 months post-transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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Renal or liver transplant recipients who underwent transplantation at National Taiwan University Hospital, and were treated with tacrolimus.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fe-Lin Lin Wu | Contact | +886-2-3366 8784 | flwu@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Meng-Kun Tsai | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
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