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临床试验/NCT06095895
NCT06095895已完成不适用

Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2024年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Bias

研究概览

简要总结

This is a prospective observational study of MIPD in clinical practice for paediatric kidney transplant patients using tacrolimus and mycophenolic acid in Radboudumc. Dose individualization in paediatric kidney transplant patients using the InsightRX platform is performed as standard care, meaning that a pharmacokinetic model and drug levels measured at t=0, t=1 and t=2 hours will be used to calculate the exposure. Based on the estimated exposure, the pharmacist gives a dose recommendation to the physician, who can then modify the dosage of mycophenolic acid or tacrolimus. The selected dose and the measured MPA and tacrolimus concentrations will be used to predict the future exposure. A second exposure measurement will be performed to evaluate whether our model is able to predict future exposure.

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
0 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Kidney transplant patients using tacrolimus and/or mycophenolic acid
  • Age between 0 and 18 years
  • Indication for an AUC measurement - judgement of clinician

排除标准

  • Incapacitated patients
  • No informed consent
  • Not proficient in the Dutch language

结局指标

主要结局

Bias

时间窗: 1 year

Mean prediction error

Precision

时间窗: 1 year

Root mean squared error

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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