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临床试验/NCT05330390
NCT05330390Unknown不适用

Study on the Population Pharmacokinetics and Individualized Administration of Levetiracetam in Epileptic Patients With Diabetic Kidney Disease

The Second Hospital of Shandong University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年4月4日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Blood drug concentration

研究概览

简要总结

The individualized drug delivery system of levetiracetam based on population pharmacokinetics and quantitative pharmacology model in patients with epilepsy complicated by diabetic kidney disease was established. To clarify the clinical feasibility of model-based individualized drug administration scheme.

详细描述

A quantitative pharmacological model for the development of levetiracetam in epileptic patients with diabetic nephropathy is proposed. First, a model based active levetiracetam based individualized initial dose regimen was established by using clinical simulation techniques. A simulation model was established for patients with diabetes mellitus and kidney disease, including information on patients' gender, age and other factors, diabetes mellitus, renal disease history, creatinine clearance rate, glomerular filtration rate, urinary protein level and blood lipid level. Secondly, the simulated clinical trial combining simulation model and population pharmacokinetic model is used to compare the compliance rate of levetiracetam blood concentration in patients with different dose treatment schemes, so as to obtain the optimal individualized administration scheme. Finally, Bayesian feedback technology is used to improve the passive dose adjustment scheme, and model-based Bayesian feedback technology is used to establish a dose adjustment scheme based on area under curve (AUC), so as to clarify the optimal blood sampling scheme and monitoring method.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with seizures and diabetic nephropathy who were treated with levetiracetam.

排除标准

  • patients who rejected

结局指标

主要结局

Blood drug concentration

时间窗: through study completion, an average of 1 year

After treating with levetiracetam, blood samples were collected at different time periods

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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