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

• Conditions: Epilepsy; Diabetic Nephropathy

• Registration Number: NCT05330390
• Lead Sponsor: The Second Hospital of Shandong University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-03
• Study Start: 2022-04-04
• Study First Submitted QC: 2022-04-09
• Last Update Submitted: 2022-04-09
• Study First Posted: 2022-04-15
• Last Update Posted: 2022-04-15
• Primary Completion: 2023-08-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• patients who rejected

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood drug concentration	through study completion, an average of 1 year	After treating with levetiracetam, blood samples were collected at different time periods

Trial Locations

Locations (1)

Second Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China