NCT05277792招募中不适用
Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients
Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年5月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Comparison of blood concentration of TAC metabolites between patients presenting TAC related side effects or not.
研究概览
简要总结
The purpose of this study is to evaluate if concentration of tacrolimus metabolites is increased in patients presenting tacrolimus (TAC) side effects.
详细描述
The study will evaluate whether the blood concentration of TAC metabolites (13-O-desmethyl-tacrolimus, 15-O-desmethyl-tacrolimus and 31-O-desmethyl-tacrolimus), measured between Day1 and Day5 of its introduction, is increased in patients with TAC toxicity.
A blood test will be performed daily from Day1 to Day5 for the measurement of TAC concentration and TAC metabolites concentration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Adult patients (> 18 years) of both sexes,
- •Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease,
- •Not having expressed their opposition to participation in the study
排除标准
- •Associated transplantation of another organ
- •Contraindications to TAC administration
- •Delayed introduction of TAC (beyond the 5th postoperative day) whatever the cause.
结局指标
主要结局
Comparison of blood concentration of TAC metabolites between patients presenting TAC related side effects or not.
时间窗: Day 5
次要结局
未报告次要终点
研究者
研究点 (1)
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