NCT00166829Unknown4 期
The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients
研究概览
简要总结
The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.
详细描述
The controlled clinical trial held in NTUH in 2001 revealed that the bioavailability of tacrolimus when combined with sirolimus is lower than that reported in the literature where tacrolimus was not combined with sirolimus. To determine if the difference was due to the drug interaction between sirolimus and tacrolimus, a controlled clinical trial was proposed.
The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •De novo kidney transplant patients
- •Aged 13 - 65 years
- •Having aminotransferase concentrations within 2 times the upper limit of normal
排除标准
- •Pregnancy
- •Tuberculosis
- •Hepatitis B or C carrier status
- •Human immunodeficiency virus-positive status
- •Retransplantation or multi-organ transplantation
- •History of rheumatoid arthritis
结局指标
主要结局
The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients
次要结局
- Compare the outcome of tacrolimus/sirolimus and tacrolimus/mycophenolate in rejection prevention
研究者
研究点 (2)
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