Evaluation of Endothelial Dysfunction in Geriatric Non-dialysis Chronic Kidney Disease Patients (EDGeriatrCKD)

February 20, 2026 updated by: Alper Alp, Muğla Sıtkı Koçman University

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,

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Muğla
      • Muğla, Muğla, Turkey (Türkiye), 48000
        • Mugla Sitki Kocman University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with CKD who are not receiving RRT and those aged 65 and over

Exclusion Criteria:

  • Patients under 65 years of age
  • history of coronary artery disease
  • history of peripheral artery disease
  • atrial fibrillation
  • heart failure
  • active immunosuppressive use
  • active infection
  • history of active malignancy
  • history of cerebrovascular event (ischemic/hemorrhagic)
  • Raynaud's phenomenon
  • renal transplant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: STUDY GROUP
THE ONLY GROUP IN THE STUDY.MEASUREMENT OF CIMT,FMD,NC.
Diagnostic test: Ultrasonographic and Capillary Measurements
All measurements will be applied to the entire patient group.
Other Names:
  • measurement of flow-mediated dilation
  • measurement of nailfold capillaroscopy
  • measurement of ultrasonographic carotid intima-media thickness

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.
Evaluation of those who died and those who survived after approximately over 2 years.
After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Muğla Sıtkı Koçman University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alper Alp, Assoc Prof,MD, Muğla Sıtkı Koçman University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23/159/02/3/4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual data from this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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