Precision Drug Use of Immunosuppressants Guided by Population Pharmacokinetics/Pharmacodynamic Models in Kidney Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Drug plasma tough concentrations
研究概览
简要总结
- Construct a population pharmacokinetic/pharmacodynamic model of tacrolimus in kidney transplant patients, and explore the quantitative relationship between combination drugs and gene polymorphisms on the safety and efficacy of tacrolimus in kidney transplant patients;
- Based on the established pharmacokinetic/pharmacodynamic model of tacrolimus population in kidney transplant patients, combined with combined drugs, gene polymorphisms and other factors for simulation, predict the steady-state trough concentration and efficacy of tacrolimus in kidney transplant patients taking triple drugs (tacrolimus, mycophenolate mofetil/mycophenol sodium enteric-coated tablets, glucocorticoids), and apply the model to the real world to explore the optimal initial dose and maintenance therapeutic dose of tacrolimus, so as to achieve individualized and precise treatment and guide the rational clinical use of drugs.
- Clarify the value of precision medicine guided by population pharmacokinetics/pharmacodynamics models in clinical practice.
详细描述
This is a retrospective study. It is proposed to combine the classical basic principles of pharmacokinetics with mathematical statistical models, and use nonlinear mixed effect model (NONMEM) or other population pharmacokinetics/pharmacodynamics software to establish a population pharmacokinetic/pharmacodynamic model of tacrolimus in kidney transplant patients, and elucidate the combination of drugs, demographic factors, pathophysiological factors, genotype, The quantitative effect of comorbid diseases and drugs on the steady-state trough concentration and efficacy of tacrolimus in kidney transplant patients, so as to realize individualized and precise treatment of kidney transplant patients through model simulation and prediction of steady-state trough concentration and efficacy after taking drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing kidney transplantation for the first time.
- •Anti-rejection therapy with triple immunosuppressant (tacrolimus + mycophenolate mofetil + glucocorticoids).
排除标准
- •The patient's medication status is unclear and there is a lack of relevant results of laboratory test indicators.
- •The patient has undergone multi-organ or combined liver and kidney transplantation or has a history of liver and kidney transplantation.
- •Transplantation failure or death.
结局指标
主要结局
Drug plasma tough concentrations
时间窗: Blood samples were collected 30minutes before administration
The tough concentrations of tacrolimus are as regard as the PK parameters
Immune factors levels(CD4+、CD8+、CD4+/CD8+、CD4+%、CD8+%)
时间窗: The Immune factors levels were collected 30minutes before administration
The Immune factors levels are as regard as the PD parameters
次要结局
- Clinical indicators(Follow-up after kidney transplantation was 6 months)