NCT02877628已完成不适用
Immunosuppressive Therapy Optimization: Development of a Population Pharmacokinetic-pharmacodynamic (PK-PD) Model in Liver Transplantation
Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2015年10月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Prediction of calcineurin inhibition, responsible for the immunosuppressive effect
研究概览
简要总结
Prospective, non-randomized, open Pharmacokinetic-Pharmacogenetic-Pharmacodynamic monocentric study. Donor and recipient CYP3A5 genotype and recipient ABCB1 will not be communicate to clinicians or patients during the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Adults over 18
- •Liver transplant recipients
- •Treated with an immunosuppressive protocol with tacrolimus
- •Informed on the study and who did not refuse to participate
排除标准
- •Patients who participate in a study with procedures incompatible with the present study.
- •Patients with legal protection/deprived of liberty.
结局指标
主要结局
Prediction of calcineurin inhibition, responsible for the immunosuppressive effect
时间窗: Week 24
Assessement of the relationships between intracellular concentration of tacrolimus and/or calcineurin activity and ACR, in patients treated with immediate release or modified-release formulation of tacrolimus
次要结局
- Evaluation of the role of the measurement of intracellular concentration as a longitudinal biomarker in preventing acute cellular graft (ACR)(Week 24)
- Study of variability of tacrolimus intracellular concentration according to its pharmaceutic form (immediate or sustained release)(Week 24)
- Study of impact of pharmacogenetic and demographic data on tacrolimus intracellular concentration(Week 24)
研究者
研究点 (1)
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