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

• Sponsor: The Second Hospital of Shandong University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05330390
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 20.9
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy; Diabetic Nephropathy	Drug: Levetiracetam

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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Study on the Population Pharmacokinetics and Individualized Administration of Levetiracetam in Epileptic Patients With Diabetic Kidney Disease
• Anticipated Study Start Date: Apr 4, 2022
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Outcome Measures

Primary Outcome Measures

1. Blood drug concentration [through study completion, an average of 1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

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

Exclusion Criteria:

• patients who rejected

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Hospital of Shandong University	Jinan	Shandong	China	250033

Sponsors and Collaborators

• The Second Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Second Hospital of Shandong University
• ClinicalTrials.gov Identifier: NCT05330390
• Other Study ID Numbers: byssc1985-2022
• First Posted: Apr 15, 2022
• Last Update Posted: Apr 15, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by The Second Hospital of Shandong University: Levetiracetam; Population pharmacokinetics
• Additional relevant MeSH terms: Kidney Diseases; Diabetic Nephropathies; Levetiracetam

Study Results

No Results Posted as of Apr 15, 2022