EpilepsyNCT07288788
Assessment of Kidney Function in Patients With Epilepsy
An observational study of Epilepsy, run by Sohag University at 2 sites in Egypt.
Trial summary
This observational cross-sectional study aims to assess kidney function in pediatric patients with epilepsy attending Sohag University Hospital. The study evaluates renal biochemical markers, urinalysis, liver functions, abdominal ultrasonography, and the possible renal effects of long-term antiepileptic drug (AED)… Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Standard Clinical Observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 28 Sep 2025to 28 Sep 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients admitted to Sohag University Hospital. Observational data will be collected from medical records.
Who may be able to join
- Age: children between 1month and 15years old.
- Both sexes.
- children who suffering from idiopathic epilepsy
Who cannot join
- Age: children below 1month old\& children above 15 years old.
- Children suffer from convulsions due to CNS infection
- Children with non idiobathic epilepsy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 1 recruiting
- Recruiting
Sohag University
Sohag
mohamed hassan ahmed, MBBS, 01146167336, Mohamedhassanfonn2@gmail.com
- Active, not recruiting
Sohage Faculty of Medicine
Sohag
About this study
This observational cross-sectional study aims to assess kidney function in pediatric patients with epilepsy attending Sohag University Hospital. The study evaluates renal biochemical markers, urinalysis, liver functions, abdominal ultrasonography, and the possible renal effects of long-term antiepileptic drug (AED) therapy.
Read the detailed description
Epilepsy is one of the most common neurological disorders requiring long-term antiepileptic drug therapy. Many AEDs are metabolized hepatically but excreted renally, which may affect kidney function, especially with long-term use. Several AEDs-including topiramate, zonisamide, acetazolamide, carbamazepine, and valproate-have been associated with nephrolithiasis, tubular dysfunction, nephrotoxicity, and acute kidney injury.
The study evaluates renal function among children with idiopathic epilepsy using clinical assessment, laboratory markers (CBC, serum creatinine, electrolytes, ABG, urinalysis, liver functions), EEG findings, and abdominal ultrasound. The purpose is to estimate the prevalence of renal affection and its possible relation to AED use.
This observational cross-sectional study evaluates renal function in pediatric patients with epilepsy by measuring serum creatinine levels at the time of enrollment. The study will enroll children of various ages and both sexes, representing multiple epilepsy types and receiving different antiepileptic drug regimens.
Comprehensive baseline data, including demographic characteristics, medical history, seizure type and frequency, and current medication usage, will be collected. Venous blood samples will be obtained for serum creatinine measurement using validated clinical laboratory methods, ensuring standardized assessment of renal function.
The study's primary objective is to determine baseline renal function in this population and to investigate potential associations between antiepileptic drug therapy and renal outcomes. Secondary analyses will explore correlations between serum creatinine levels and patient-specific factors such as age, sex, epilepsy type, duration of therapy, and comorbidities.
All data will be handled in accordance with institutional and regulatory guidelines for clinical research. The results are intended to inform clinical monitoring practices, optimize antiepileptic drug management, and support future research on kidney function in children with epilepsy.
- Conditions
- Epilepsy
- Being tested
- Standard Clinical Observation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Clinical ObservationBehavioural
Observational study of pediatric patients admitted to Sohag University Hospital. No experimental treatment or device is administered. Data collection only.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Observational study of pediatric patients admitted to Sohag University Hospital Receives: Behavioral: Standard Clinical Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine level in pediatric epilepsy patients
Measurement of serum creatinine in pediatric patients at enrollment to assess renal function related to epilepsy or antiepileptic drug use
Measured: At enrollment (single cross-sectional assessment)
Secondary outcomes (5)
Prevalence of nephrolithiasis / nephrocalcinosis
Presence of renal calculi or nephrocalcinosis detected by abdominal ultrasound performed at enrollment.
Measured: At enrollment (single cross-sectional assessment)
Electrolyte disturbances
Frequency of clinically significant electrolyte abnormalities (e.g., hypokalemia, hypernatremia, bicarbonate reduction) measured in serum chemistry at enrollment.
Measured: At enrollment (single cross-sectional assessment)
Abnormal urinalysis findings
Proportion of participants with abnormal urine analysis results (proteinuria, hematuria, crystalluria, or other abnormalities) at enrollment.
Measured: At enrollment (single cross-sectional assessment)
Association between AED regimen and renal parameters
Comparison of renal function markers (serum creatinine, urinalysis, ultrasound findings) across groups defined by type of antiepileptic drug(s) used (e.g., renally excreted vs. non-renally excreted drugs) at enrollment.
Measured: At enrollment (single cross-sectional assessment)
Abdominal Ultrasound Findings
Detection of renal structural abnormalities including nephrolithiasis or nephrocalcinosis.
Measured: At enrollment (single cross-sectional assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start28 Sep 2025
- Primary completion28 Sep 2025
- Study completion28 Sep 2026 (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.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hassan Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288788
- Sponsor's protocol ID
- Soh-Med--25-9-2MS
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Kidney Function in Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT07288788
- Acronym / sponsor ID
- Soh-Med--25-9-2MS
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 28 Sep 2025 (actual)
- Primary completion
- 28 Sep 2025 (actual)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 17 Dec 2025 (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.
This observational cross-sectional study aims to assess kidney function in pediatric patients with epilepsy attending Sohag University Hospital. The study evaluates renal biochemical markers, urinalysis, liver functions, abdominal ultrasonography, and the possible renal effects of long-term antiepileptic drug (AED) therapy.
Detailed description
Epilepsy is one of the most common neurological disorders requiring long-term antiepileptic drug therapy. Many AEDs are metabolized hepatically but excreted renally, which may affect kidney function, especially with long-term use. Several AEDs-including topiramate, zonisamide, acetazolamide, carbamazepine, and valproate-have been associated with nephrolithiasis, tubular dysfunction, nephrotoxicity, and acute kidney injury.
The study evaluates renal function among children with idiopathic epilepsy using clinical assessment, laboratory markers (CBC, serum creatinine, electrolytes, ABG, urinalysis, liver functions), EEG findings, and abdominal ultrasound. The purpose is to estimate the prevalence of renal affection and its possible relation to AED use.
This observational cross-sectional study evaluates renal function in pediatric patients with epilepsy by measuring serum creatinine levels at the time of enrollment. The study will enroll children of various ages and both sexes, representing multiple epilepsy types and receiving different antiepileptic drug regimens.
Comprehensive baseline data, including demographic characteristics, medical history, seizure type and frequency, and current medication usage, will be collected. Venous blood samples will be obtained for serum creatinine measurement using validated clinical laboratory methods, ensuring standardized assessment of renal function.
The study's primary objective is to determine baseline renal function in this population and to investigate potential associations between antiepileptic drug therapy and renal outcomes. Secondary analyses will explore correlations between serum creatinine levels and patient-specific factors such as age, sex, epilepsy type, duration of therapy, and comorbidities.
All data will be handled in accordance with institutional and regulatory guidelines for clinical research. The results are intended to inform clinical monitoring practices, optimize antiepileptic drug management, and support future research on kidney function in children with epilepsy.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Behavioral: Standard Clinical ObservationObservational study of pediatric patients admitted to Sohag University Hospital |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients admitted to Sohag University Hospital. Observational data will be collected from medical records.
Key inclusion criteria (3 listed)
- Age: children between 1month and 15years old.
- Both sexes.
- children who suffering from idiopathic epilepsy
Key exclusion criteria (3 listed)
- Age: children below 1month old\& children above 15 years old.
- Children suffer from convulsions due to CNS infection
- Children with non idiobathic epilepsy
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 |
|---|---|---|
| Standard Clinical ObservationObservational study of pediatric patients admitted to Sohag University Hospital. No experimental treatment or device is administered. Data collection only. | Behavioural | All Participants |
Primary outcome
Serum creatinine level in pediatric epilepsy patients
Time frame: At enrollment (single cross-sectional assessment)
Measurement of serum creatinine in pediatric patients at enrollment to assess renal function related to epilepsy or antiepileptic drug use
5 secondary outcomes
Prevalence of nephrolithiasis / nephrocalcinosis
Time frame: At enrollment (single cross-sectional assessment)
Electrolyte disturbances
Time frame: At enrollment (single cross-sectional assessment)
Abnormal urinalysis findings
Time frame: At enrollment (single cross-sectional assessment)
Association between AED regimen and renal parameters
Time frame: At enrollment (single cross-sectional assessment)
Abdominal Ultrasound Findings
Time frame: At enrollment (single cross-sectional assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Sohag University at 2 sites in Egypt.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mohamed hassan hassan, resident (01146167336, Mohamedhassanfonn2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatinine level in pediatric epilepsy patients (time frame: At enrollment (single cross-sectional assessment)). 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 17 Dec 2025.