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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05330390
Enrollment
50
Registered
2022-04-15
Start date
2022-04-04
Completion date
2023-12-31
Last updated
2022-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy, Epilepsy

Keywords

Levetiracetam, Population pharmacokinetics

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.

Interventions

DRUGLevetiracetam

Epilepsy, treatment with levetiracetam

Sponsors

The Second Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

Inclusion criteria

\- Patients with seizures and diabetic nephropathy who were treated with levetiracetam.

Exclusion criteria

* patients who rejected

Design outcomes

Primary

MeasureTime frameDescription
Blood drug concentrationthrough study completion, an average of 1 yearAfter treating with levetiracetam, blood samples were collected at different time periods

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026