Chronic Kidney DiseasesNCT07859371
Clinical and Bioelectrical Impedance Profiles in Children With CKD
An observational study of Chronic Kidney Diseases, run by Assiut University.
Trial summary
This cross-sectional study aims to assess body composition and hydration status using bioelectrical impedance analysis in children with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 25 Feb 2028
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 6 to 18 years with chronic kidney disease attending the Pediatric Nephrology outpatient clinic or admitted to Assiut University Children Hospital.
Who may be able to join
- - Age 6 to 18 years
- Diagnosed chronic kidney disease according to KDIGO criteria
- Duration of kidney disease of at least 3 months
- Written informed consent from parent or guardian
Who cannot join
- - Acute kidney injury
- Cardiac pacemaker or implanted electrical devices
- Major limb amputation
- Acute infection
- Massive edema due to causes other than CKD
- Chronic liver disease
- Malignancy
- Inability to undergo bioelectrical impedance analysis measurement
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Bioelectrical Impedance Profiles in Children With Chronic Kidney Disease
This cross-sectional study aims to assess body composition and hydration status using bioelectrical impedance analysis in children with chronic kidney disease.
Read the detailed description
Chronic kidney disease in children is associated with abnormalities in body composition and fluid balance that may not be fully detected by conventional anthropometric measurements.
This observational study will evaluate body composition and hydration parameters using bioelectrical impedance analysis in children with chronic kidney disease aged 6 to 18 years attending Assiut University Children Hospital.
- Conditions
- Chronic Kidney Diseases
- Keywords
- Bioelectrical impedance analysis, Chronic kidney disease, Body composition, Hydration status, Phase angle, Assiut
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with Chronic Kidney Disease | Children aged 6 to 18 years with chronic kidney disease according to KDIGO criteria attending the Pediatric Nephrology Unit at Assiut University Children Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean phase angle
Mean phase angle measured by bioelectrical impedance analysis in degrees.
Measured: Baseline
Secondary outcomes (6)
Mean total body water
Mean total body water measured by bioelectrical impedance analysis in liters.
Measured: Baseline
Mean extracellular water
Mean extracellular water measured by bioelectrical impedance analysis in liters.
Measured: Baseline
Mean fat-free mass
Mean fat-free mass measured by bioelectrical impedance analysis in kilograms.
Measured: Baseline
Mean body mass index
Mean body mass index in kg/m².
Measured: Baseline
Mean serum albumin
Mean serum albumin level in g/dL.
Measured: Baseline
Proportion of children with overhydration
Proportion of children classified as overhydrated according to bioelectrical impedance analysis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion25 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Gamal Sayed, Assiut University
- Investigators
- Mostafa S Khalaf, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859371
- Sponsor's protocol ID
- BIA-CKD-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Bioelectrical Impedance Profiles in Children With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07859371
- Acronym / sponsor ID
- BIA-CKD-Assiut-2026
- Conditions
- Chronic Kidney Diseases
- Keywords
- Bioelectrical impedance analysis, Chronic kidney disease, Body composition, Hydration status, Phase angle, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 25 Feb 2028 (estimated)
- First posted
- 5 Oct 2026 (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 cross-sectional study aims to assess body composition and hydration status using bioelectrical impedance analysis in children with chronic kidney disease.
Detailed description
Chronic kidney disease in children is associated with abnormalities in body composition and fluid balance that may not be fully detected by conventional anthropometric measurements.
This observational study will evaluate body composition and hydration parameters using bioelectrical impedance analysis in children with chronic kidney disease aged 6 to 18 years attending Assiut University Children Hospital.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Chronic Kidney Disease | – | –Children aged 6 to 18 years with chronic kidney disease according to KDIGO criteria attending the Pediatric Nephrology Unit at Assiut University Children Hospital. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 6 to 18 years with chronic kidney disease attending the Pediatric Nephrology outpatient clinic or admitted to Assiut University Children Hospital.
Key inclusion criteria (4 listed)
- - Age 6 to 18 years
- Diagnosed chronic kidney disease according to KDIGO criteria
- Duration of kidney disease of at least 3 months
- Written informed consent from parent or guardian
Key exclusion criteria (8 listed)
- - Acute kidney injury
- Cardiac pacemaker or implanted electrical devices
- Major limb amputation
- Acute infection
- Massive edema due to causes other than CKD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean phase angle
Time frame: Baseline
Mean phase angle measured by bioelectrical impedance analysis in degrees.
6 secondary outcomes
Mean total body water
Time frame: Baseline
Mean extracellular water
Time frame: Baseline
Mean fat-free mass
Time frame: Baseline
Mean body mass index
Time frame: Baseline
Mean serum albumin
Time frame: Baseline
Proportion of children with overhydration
Time frame: Baseline
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Mostafa S Khalaf, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Assiut University.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mahmoud G Sayed, Resident (+20 10 67561049, mahmoudgamal9991122@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean phase angle (time frame: Baseline). 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 5 Oct 2026.