NCT01055964已完成3 期
a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- pharmacokinetics
研究概览
简要总结
The aim of this study is to identify the pharmacokinetic differences between two oral forms of Tacrolimus and consequent nephrotoxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ABO-compatible renal transplant recipients
排除标准
- •multi-organ transplant
- •HIV(+) donor or recipients
- •history of malignancy other than skin cancer (except completely cured basal cell ca or squamous cell ca)
- •more than three-fold increase in AST or ALT level for 28 days
- •pregnancy
- •lactation
研究组 & 干预措施
Tacrobell
Experimental
干预措施: Tacrolimus (Drug)
Prograf
Active Comparator
干预措施: Tacrolimus (Drug)
结局指标
主要结局
pharmacokinetics
时间窗: at postoperative 10~14 days and at postoperative 6 months for crossover study
次要结局
未报告次要终点
研究者
Jongwon Ha
Professor
Seoul National University Hospital
研究点 (1)
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