The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism and Other Factors on Tacrolimus Blood Concentration
试验速览
- 阶段
- 不适用
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Dose-normalized tacrolimus concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •kidney transplants or liver transplants
- •20 - 65 years old
- •receiving tacrolimus as immunosuppressive drugs
排除标准
- •Human immunodeficiency virus-positive status
- •Retransplantation or multiorgan transplantation
- •non-Asian
结局指标
主要结局
Dose-normalized tacrolimus concentration
时间窗: Within the first 6 months post-transplantation
次要结局
未报告次要终点