NCT07430982

Brief 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 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,

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2023

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
Last Updated

February 24, 2026

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

February 12, 2026

Last Update Submit

February 20, 2026

Conditions

Keywords

geriatricschronic kidney diseasesoluble vascular endothelial cadherinFGF-23

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    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

    After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.

Study Arms (1)

STUDY GROUP

OTHER

THE ONLY GROUP IN THE STUDY.MEASUREMENT OF CIMT,FMD,NC.

Diagnostic Test: Ultrasonographic and Capillary Measurements

Interventions

All measurements will be applied to the entire patient group.

Also known as: measurement of flow-mediated dilation, measurement of nailfold capillaroscopy, measurement of ultrasonographic carotid intima-media thickness
STUDY GROUP

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sitki Kocman University

Muğla, Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 35806017BACKGROUND
  • Soeki 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.

    PMID: 14695457BACKGROUND
  • Chang 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.

    PMID: 28561330BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alper Alp, Assoc Prof,MD

    Muğla Sıtkı Koçman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, MD

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 24, 2026

Study Start

May 12, 2023

Primary Completion

September 11, 2023

Study Completion

February 1, 2026

Last Updated

February 24, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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

Locations