Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment
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
- 否
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
