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NCT07686978

Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls

Sponsor: Gazi University

View on ClinicalTrials.gov

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.

Official title: Prospective Comparative Evaluation of the Biochemical and Clinical Effects of Different Dialysis Modalities on Cardiovascular Status and Bone Mineral Metabolism

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-07

Completion Date

2027-07

Last Updated

2026-07-07

Healthy Volunteers

Yes

Locations (1)

Gazi University Faculty of Medicine, Department of Nephrology

Ankara, Ankara, Turkey (Türkiye)