GeriatricsEDGeriatrCKDNCT07430982
Evaluation of Endothelial Dysfunction in Geriatric Non-dialysis Chronic Kidney Disease Patients
A study testing Ultrasonographic and Capillary Measurements in people with Geriatrics and Chronic Kidney Disease, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
Brief summary template The goal of this clinical trial is to assess endothelial dysfunction in geriatric non-dialysis CKD patients. The main questions it aims to answer are: In geriatric non-dialysis CKD patients, the study aimed to demonstrate the relationship between soluble vascular endothelial cadherin and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatrics, Chronic Kidney Disease, Carotis Intima-media Thickness
- What is being tested?
- Ultrasonographic and Capillary Measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2023to 1 Feb 2026
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients diagnosed with CKD who are not receiving RRT and those aged 65 and over
Who cannot join
- Patients under 65 years of age
- history of coronary artery disease
- history of peripheral artery disease
- atrial fibrillation
- heart failure
- active immunosuppressive use
Show all 11Show fewer
- active infection
- history of active malignancy
- history of cerebrovascular event (ischemic/hemorrhagic)
- Raynaud's phenomenon
- renal transplant patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sitki Kocman University
Muğla, Muğla, 48000
About this study
Brief summary template
The goal of this clinical trial is to assess endothelial dysfunction in geriatric non-dialysis CKD patients. The main questions it aims to answer are:
Read more
- In geriatric non-dialysis CKD patients, the study aimed to demonstrate the relationship between soluble vascular endothelial cadherin and fibroblast growth factor-23 levels, which are indicators of endothelial dysfunction-and therefore a possible cardiovascular risk factor-using measurement methods such as ultrasonographic carotid intima-media thickness, flow-mediated dilation, and nailfold capillaroscopy.
Participants will have measurement of;
- ultrasonographic carotid intima-media thickness,
- flow-mediated dilation,
- nailfold capillaroscopy
- venous blood sampling
- Visit the clinic once,
Read the detailed description
In this single-center study, we aimed to evaluate endothelial dysfunction, the leading cause of mortality in geriatric CKD patients. We kept patient exclusion criteria strict and considered it more rational to conduct this study in a patient group requiring proactive intervention by excluding patients with 'known' cardiovascular disease. For this purpose, we used some non-invasive parameters known in the literature (ultrasonographic measurement of carotid intima-media thickness, nailfold capillaroscopy, flow-mediated dilation). We also planned to measure serum sVE Cadherin levels, which have not been clearly evaluated in geriatric CKD patients before, as well as serum FGF23 levels. We also planned to evaluate the relationship and correlation of these different parameters with other standard biochemical and anthropometric measurements. Patient recruitment for the study took place between May 12, 2023, and September 11, 2023. We followed up for mortality for approximately 2.3 years.
- Being tested
- Ultrasonographic and Capillary Measurements
- Keywords
- geriatrics, chronic kidney disease, soluble vascular endothelial cadherin, FGF-23
- 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.
Ultrasonographic and Capillary MeasurementsDiagnostic test
Also called measurement of flow-mediated dilation, measurement of nailfold capillaroscopy, measurement of ultrasonographic carotid intima-media thickness
All measurements will be applied to the entire patient group.
| Study group | Role | What they receive |
|---|---|---|
| STUDY GROUP | Other | THE ONLY GROUP IN THE STUDY.MEASUREMENT OF CIMT,FMD,NC. Receives: Diagnostic Test: Ultrasonographic and Capillary Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of serum sVE cadherin level and other measurements
To investigate the relationship between sVE cadherin levels and ultrasonographic carotid intima-media thickness (CIMT), flow-mediated dilation(FMD), nailfold capillaroscopy(NC) test results measured in patients.
Measured: Approximately 122 days were sufficient for patient recruitment for the study. After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.
Distribution of sVE cadherin levels in the patient group
sVE cadherin levels
Measured: Approximately 122 days were sufficient for patient recruitment for the study. After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.
Secondary outcomes (1)
All-cause mortality
Evaluation of those who died and those who survived after approximately over 2 years.
Measured: After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start12 May 2023
- Primary completion11 Sep 2023
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GeriatricsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Alp, Muğla Sıtkı Koçman University
- Investigators
- Alper Alp, Assoc Prof,MD, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430982
- Sponsor's protocol ID
- 23/159/02/3/4
- Acronym
- EDGeriatrCKD
- Status last verified
- Mar 2025
- First submitted
- 12 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual data from this study.
Publications
Harki O, Bouyon S, Salle M, Arco-Hierves A, Lemarie E, Demory A, Chirica C, Vilgrain I, Pepin JL, Faury G, Briancon-Marjollet A. Inhibition of Vascular Endothelial Cadherin Cleavage Prevents Elastic Fiber Alterations and Atherosclerosis Induced by Intermittent Hypoxia in the Mouse Aorta. Int J Mol Sci. 2022 Jun 24;23(13):7012. doi: 10.3390/ijms23137012.
PubMed 35806017Soeki T, Tamura Y, Shinohara H, Sakabe K, Onose Y, Fukuda N. Elevated concentration of soluble vascular endothelial cadherin is associated with coronary atherosclerosis. Circ J. 2004 Jan;68(1):1-5. doi: 10.1253/circj.68.1.
PubMed 14695457Chang F, Flavahan S, Flavahan NA. Impaired activity of adherens junctions contributes to endothelial dilator dysfunction in ageing rat arteries. J Physiol. 2017 Aug 1;595(15):5143-5158. doi: 10.1113/JP274189. Epub 2017 Jun 30.
PubMed 28561330
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endothelial Dysfunction in Geriatric Non-dialysis Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT07430982
- Acronym / sponsor ID
- EDGeriatrCKD / 23/159/02/3/4
- Keywords
- geriatrics, chronic kidney disease, soluble vascular endothelial cadherin, FGF-23
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 24 Feb 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.
Brief summary template
The goal of this clinical trial is to assess endothelial dysfunction in geriatric non-dialysis CKD patients. The main questions it aims to answer are:
- In geriatric non-dialysis CKD patients, the study aimed to demonstrate the relationship between soluble vascular endothelial cadherin and fibroblast growth factor-23 levels, which are indicators of endothelial dysfunction-and therefore a possible cardiovascular risk factor-using measurement methods such as ultrasonographic carotid intima-media thickness, flow-mediated dilation, and nailfold capillaroscopy.
Participants will have measurement of;
- ultrasonographic carotid intima-media thickness,
- flow-mediated dilation,
- nailfold capillaroscopy
- venous blood sampling
- Visit the clinic once,
Detailed description
In this single-center study, we aimed to evaluate endothelial dysfunction, the leading cause of mortality in geriatric CKD patients. We kept patient exclusion criteria strict and considered it more rational to conduct this study in a patient group requiring proactive intervention by excluding patients with 'known' cardiovascular disease. For this purpose, we used some non-invasive parameters known in the literature (ultrasonographic measurement of carotid intima-media thickness, nailfold capillaroscopy, flow-mediated dilation). We also planned to measure serum sVE Cadherin levels, which have not been clearly evaluated in geriatric CKD patients before, as well as serum FGF23 levels. We also planned to evaluate the relationship and correlation of these different parameters with other standard biochemical and anthropometric measurements. Patient recruitment for the study took place between May 12, 2023, and September 11, 2023. We followed up for mortality for approximately 2.3 years.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STUDY GROUP | Other | Diagnostic Test: Ultrasonographic and Capillary MeasurementsTHE ONLY GROUP IN THE STUDY.MEASUREMENT OF CIMT,FMD,NC. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with CKD who are not receiving RRT and those aged 65 and over
Key exclusion criteria (11 listed)
- Patients under 65 years of age
- history of coronary artery disease
- history of peripheral artery disease
- atrial fibrillation
- heart failure
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 |
|---|---|---|
| Ultrasonographic and Capillary MeasurementsAlso: measurement of flow-mediated dilation, measurement of nailfold capillaroscopy, measurement of ultrasonographic carotid intima-media thicknessAll measurements will be applied to the entire patient group. | Diagnostic test | STUDY GROUP |
Primary outcome
Correlation of serum sVE cadherin level and other measurements
Time frame: Approximately 122 days were sufficient for patient recruitment for the study. After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.
To investigate the relationship between sVE cadherin levels and ultrasonographic carotid intima-media thickness (CIMT), flow-mediated dilation(FMD), nailfold capillaroscopy(NC) test results measured in patients.
Distribution of sVE cadherin levels in the patient group
Time frame: Approximately 122 days were sufficient for patient recruitment for the study. After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.
sVE cadherin levels
1 secondary outcome
All-cause mortality
Time frame: After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 35806017Harki O, Bouyon S, Salle M, Arco-Hierves A, Lemarie E, Demory A, Chirica C, Vilgrain I, Pepin JL, Faury G, Briancon-Marjollet A. Inhibition of Vascular Endothelial Cadherin Cleavage Prevents Elastic Fiber Alterations and Atherosclerosis Induced by Intermittent Hypoxia in the Mouse Aorta. Int J Mol Sci. 2022 Jun 24;23(13):7012. doi: 10.3390/ijms23137012.
- Background: PubMed 14695457Soeki T, Tamura Y, Shinohara H, Sakabe K, Onose Y, Fukuda N. Elevated concentration of soluble vascular endothelial cadherin is associated with coronary atherosclerosis. Circ J. 2004 Jan;68(1):1-5. doi: 10.1253/circj.68.1.
- Background: PubMed 28561330Chang F, Flavahan S, Flavahan NA. Impaired activity of adherens junctions contributes to endothelial dilator dysfunction in ageing rat arteries. J Physiol. 2017 Aug 1;595(15):5143-5158. doi: 10.1113/JP274189. Epub 2017 Jun 30.
- Individual participant dataSharing planned: No. There is no plan to share individual data from this study.
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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.
Alper Alp, Assoc Prof,MD principal investigator
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonographic and Capillary Measurements in people with Geriatrics and Chronic Kidney Disease, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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 11 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: finished, as of the sponsor's last update on 24 Feb 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of serum sVE cadherin level and other measurements (time frame: Approximately 122 days were sufficient for patient recruitment for the study. After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07430982, which also lists 3 linked publications.
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 24 Feb 2026.