NCT01904045已完成不适用
A Multicentre, Prospective, Non-Interventional Study to Assess the Intra-patient Variability of Tacrolimus Once and Twice Daily After Kidney Transplantation
Technical University of Munich1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2013年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Intrapatient variability of tacrolimus through level
研究概览
简要总结
Aim of this study is to investigate whether in patients following kidney transplantation (>6 months after transplantation), the intra-patient variability of levels of tacrolimus is comparable after administration of tacrolimus twice daily (Prograf) to tacrolimus once daily (Advagraf), with each regimen for 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed written informed consent
- •male or female patient ≥ 18years of age
- •Patient has received a kidney transplantation at least 6 months prior to inclusion into the study
- •No acute rejection episodes for at least 3 months
- •PRG through level and dosing stable for at least 1 month
- •Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study
排除标准
- •Acute rejection episodes within the last 3 months prior to study entry
- •Unstable PRG trough level or dose change in the month before study entry
- •History of noncompliance to medical regimens
- •Patients unwilling to or unable to comply with the protocol
- •Treatment with another investigational product during this study or during the last 30 days prior to study start
结局指标
主要结局
Intrapatient variability of tacrolimus through level
时间窗: pre-dose, 1 h post dose and 3 h post dose for 3 month
次要结局
未报告次要终点
研究者
研究点 (1)
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