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NCT05330390 Clinical Trial

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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05330390
Other study ID # byssc1985-2022
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 4, 2022
Est. completion date December 31, 2023

Study information
Verified date April 2022
Source The Second Hospital of Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 50
Est. completion date December 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Patients with seizures and diabetic nephropathy who were treated with levetiracetam. Exclusion Criteria: - patients who rejected

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Levetiracetam
Epilepsy, treatment with levetiracetam

Locations
Country Name City State
China Second Hospital of Shandong University Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood drug concentration After treating with levetiracetam, blood samples were collected at different time periods through study completion, an average of 1 year
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