Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls

NCT07686978 | Not Yet Recruiting

• 1 other identifier: GAZI-HD-PD-2026
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study will compare cardiovascular status, bone mineral metabolism, systemic inflammation, body composition, functional status, quality of life, pruritus, and pain among patients receiving different renal replacement therapy modalities and healthy controls. Adult participants will be included in four groups: maintenance hemodialysis, continuous ambulatory peritoneal dialysis, automated peritoneal dialysis, and healthy controls. No new treatment, drug, dialysis modality, or experimental device will be assigned as part of the study. Participants will continue their routine clinical care. Serum interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1), fibroblast growth factor-23 (FGF-23), and sclerostin levels will be measured. Arterial stiffness will be assessed using pulse wave velocity (PWV), and body composition will be assessed using the Body Composition Monitor (BCM). Handgrip strength, quality of life, pruritus, and pain scores will also be evaluated. The study will also explore correlations between biochemical biomarkers, arterial stiffness, body composition, and patient-reported outcomes. In the automated peritoneal dialysis group, objective treatment adherence will additionally be assessed using the Sharesource (Baxter/Vantive) cloud-based remote patient monitoring platform.

Conditions

End-Stage Kidney Disease (ESKD); Hemodialysis; Peritoneal Dialysis (PD)

Keywords

Hemodialysis; Continuous Ambulatory Peritoneal Dialysis; Automated Peritoneal Dialysis; Sharesource; Fibroblast Growth Factor-23; Sclerostin; Interleukin-6; Vascular Cell Adhesion Molecule-1; Pulse Wave Velocity; Body Composition Monitor; Kidney Disease Quality of Life-36; Uremic Pruritus in Dialysis Patients; Short-Form McGill Pain Questionnaire

Outcome Measures

Primary Outcomes (4)

• Change in Serum Interleukin-6 (IL-6) Concentration

  Serum interleukin-6 (IL-6) concentration will be measured using enzyme-linked immunosorbent assay (ELISA). Change in serum IL-6 concentration from baseline to Month 12 will be evaluated in dialysis cohorts, and baseline IL-6 concentrations will be compared between dialysis modality groups and healthy controls.

  Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.

• Change in Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) Concentration

  Serum vascular cell adhesion molecule-1 (VCAM-1) concentration will be measured using enzyme-linked immunosorbent assay (ELISA). Change in serum VCAM-1 concentration from baseline to Month 12 will be evaluated in dialysis cohorts, and baseline VCAM-1 concentrations will be compared between dialysis modality groups and healthy controls.

  Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.

• Change in Serum Sclerostin Concentration

  Serum sclerostin concentration will be measured using enzyme-linked immunosorbent assay (ELISA). Change in serum sclerostin concentration from baseline to Month 12 will be evaluated in dialysis cohorts, and baseline sclerostin concentrations will be compared between dialysis modality groups and healthy controls.

  Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.

• Change in Serum Fibroblast Growth Factor-23 (FGF-23) Concentration

  Serum fibroblast growth factor-23 (FGF-23) concentration will be measured using enzyme-linked immunosorbent assay (ELISA). Change in serum FGF-23 concentration from baseline to Month 12 will be evaluated in dialysis cohorts, and baseline FGF-23 concentrations will be compared between dialysis modality groups and healthy controls.

  Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.

Secondary Outcomes (10)

• Change in Pulse Wave Velocity (PWV) Measured in m/s

  Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.

• Change in Handgrip Strength Measured by Hand Dynamometer

  Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.

• Change in Kidney Disease Quality of Life-36 (KDQOL-36) Score

  Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.

• Change in Uraemic Pruritus in Dialysis Patients (UP-Dial) Score

  Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.

• Change in Short-Form McGill Pain Questionnaire (SF-MPQ) Total Pain Rating Index Score

  Baseline (July 2026), Month 3 (October 2026), Month 6 (January 2027), and Month 12 (July 2027) for dialysis cohorts; baseline only (July 2026) for healthy controls.

Study Arms (4)

Maintenance Hemodialysis

Adult patients with end-stage kidney disease who have been receiving maintenance hemodialysis for at least 6 months. Participants in this cohort will continue their routine hemodialysis treatment three times weekly according to standard clinical practice. No intervention will be assigned by the study protocol. Blood samples, pulse wave velocity, body composition measurements, handgrip strength, and patient-reported outcome assessments will be performed at baseline, Month 3, Month 6, and Month 12.

Continuous Ambulatory Peritoneal Dialysis

Adult patients with end-stage kidney disease who have been receiving continuous ambulatory peritoneal dialysis (CAPD) for at least 6 months. Participants in this cohort will continue their routine CAPD treatment according to standard clinical practice. No intervention will be assigned by the study protocol. Blood samples, pulse wave velocity, body composition measurements, handgrip strength, and patient-reported outcome assessments will be performed at baseline, Month 3, Month 6, and Month 12.

Automated Peritoneal Dialysis

Adult patients with end-stage kidney disease who have been receiving automated peritoneal dialysis (APD) for at least 6 months. Participants in this cohort will continue their routine APD treatment according to standard clinical practice. No intervention will be assigned by the study protocol. Blood samples, pulse wave velocity, body composition measurements, handgrip strength, and patient-reported outcome assessments will be performed at baseline, Month 3, Month 6, and Month 12. Objective treatment adherence will also be assessed using data transferred from home cycler devices to the Sharesource cloud-based remote patient monitoring platform.

Healthy Controls

Adult healthy controls without known kidney disease, systemic inflammatory disease, or active malignancy. Healthy controls will not receive any intervention assigned by the study protocol. Baseline blood samples, pulse wave velocity, body composition measurements, handgrip strength, pain assessment, and general health-related quality of life assessment using the 12-Item Short Form Health Survey (SF-12) will be performed. Healthy controls will be evaluated at baseline only and will not undergo longitudinal follow-up.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants will be recruited from the Gazi University Faculty of Medicine nephrology outpatient clinic and dialysis units. The study population will include four cohorts: patients receiving maintenance hemodialysis, patients receiving continuous ambulatory peritoneal dialysis, patients receiving automated peritoneal dialysis, and healthy controls without known kidney disease. Dialysis patients must have been receiving regular dialysis treatment for at least 6 months. Healthy controls will have no known kidney disease, systemic inflammatory disease, or active malignancy.

You may qualify if:

• Age 18 to 80 years.
• For dialysis cohorts: diagnosis of end-stage kidney disease and receiving maintenance hemodialysis or peritoneal dialysis.
• For dialysis cohorts: receiving regular hemodialysis, continuous ambulatory peritoneal dialysis, or automated peritoneal dialysis for at least 6 months.
• For healthy controls: no known kidney disease, with estimated glomerular filtration rate greater than 90 mL/min/1.73 m².
• For healthy controls: no known systemic inflammatory disease or active malignancy.
• Able to comply with planned study procedures, including pulse wave velocity measurement, Body Composition Monitor assessment, questionnaires, and biomarker measurements.
• Able and willing to provide written informed consent.

You may not qualify if:

• Inability to comply with study measurements or questionnaire assessments.
• Refusal or inability to provide written informed consent.
• Age younger than 18 years or older than 80 years.
• Acute infection.
• Recent major surgical intervention.
• Active malignancy.
• Terminal illness with limited life expectancy.
• Mental, cognitive, physical, or clinical condition preventing participation in study procedures.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Medicine, Department of Nephrology

Ankara, Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (3)

• Vo, H.H.T.; Nguyen, T.V.H.; Phan, M.P.T.; Vo, T. Serum Sclerostin Levels and Their Association with Mineral and Bone Disorders in Hemodialysis Versus Peritoneal Dialysis Patients: A Cross-Sectional Comparative Study in Vietnam. Kidney Dial. 2026, 6, 35. https://doi.org/10.3390/kidneydial6020035

  BACKGROUND

• Lima F, Monier-Faugere MC, Mawad H, David V, Malluche HH. FGF-23 and sclerostin in serum and bone of CKD patients. Clin Nephrol. 2023 May;99(5):209-218. doi: 10.5414/CN111111.

  PMID: 36970967 BACKGROUND

• Yildirim M, Acikgoz SB, Genc AB, Yaylaci S, Dheir H, Sipahi SS. The levels of inflammatory biomarkers in hemodialysis and peritoneal dialysis patients. Rev Assoc Med Bras (1992). 2021 Jun;67(5):718-723. doi: 10.1590/1806-9282.20210056.

  PMID: 34550262 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Sclerosteosis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Veysel Baran Tomar, M.D.

CONTACT

+905334133253; veyselbarantomar@gazi.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)