EpilepsyNCT05330390
Study on the Population Pharmacokinetics of Levetiracetam in Epileptic Patients With Diabetic Kidney Disease
An observational study of Epilepsy and Diabetic Nephropathy, run by The Second Hospital of Shandong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Epilepsy, Diabetic Nephropathy
- What is being tested?
- Levetiracetam
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: The method of continuous and non random enrollment was adopted.
Who may be able to join
- Patients with seizures and diabetic nephropathy who were treated with levetiracetam.
Who cannot join
- patients who rejected
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Population Pharmacokinetics and Individualized Administration of Levetiracetam in Epileptic Patients With Diabetic Kidney Disease
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.
Read the 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.
- Conditions
- Epilepsy, Diabetic Nephropathy
- Being tested
- Levetiracetam
- Keywords
- Levetiracetam, Population pharmacokinetics
- Medical subject headings
- Epilepsy, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Epilepsy, treatment with levetiracetam
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood drug concentration
After treating with levetiracetam, blood samples were collected at different time periods
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start4 Apr 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330390
- Sponsor's protocol ID
- byssc1985-2022
- Status last verified
- Apr 2022
- First submitted
- 3 Apr 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Population Pharmacokinetics and Individualized Administration of Levetiracetam in Epileptic Patients With Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT05330390
- Acronym / sponsor ID
- byssc1985-2022
- Conditions
- Epilepsy, Diabetic Nephropathy
- Keywords
- Levetiracetam, Population pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The method of continuous and non random enrollment was adopted.
Key inclusion criteria (1 listed)
- Patients with seizures and diabetic nephropathy who were treated with levetiracetam.
Key exclusion criteria (1 listed)
- patients who rejected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevetiracetamEpilepsy, treatment with levetiracetam | Drug | – |
Primary outcome
Blood drug concentration
Time frame: through study completion, an average of 1 year
After treating with levetiracetam, blood samples were collected at different time periods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Diabetic Nephropathy, run by The Second Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood drug concentration (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.