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

NCT05330390 | Unknown FDA Drug

• 1 other identifier: byssc1985-2022
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Diabetic Nephropathy

Keywords

Levetiracetam; Population pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Blood drug concentration

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

  through study completion, an average of 1 year

Interventions

Levetiracetam DRUG

Epilepsy, treatment with levetiracetam

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The method of continuous and non random enrollment was adopted.

You may qualify if:

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

You may not qualify if:

• patients who rejected

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

Second Hospital of Shandong University

Jinan, Shandong, 250033, China

Location

MeSH Terms

Conditions

Epilepsy; Diabetic Nephropathies

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2022
• First Posted: April 15, 2022
• Study Start: April 4, 2022
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

CN (1)