Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls

Patients with end-stage kidney disease receiving renal replacement therapy have a high burden of cardiovascular disease, chronic inflammation, mineral and bone metabolism abnormalities, altered body composition, impaired quality of life, pruritus, and pain. Hemodialysis and peritoneal dialysis differ in clearance patterns, fluid management, and treatment delivery, which may influence biochemical, vascular, nutritional, and patient-reported outcomes.

This is a single-center observational clinical study including adult patients receiving routine renal replacement therapy and healthy controls. Participants will not be assigned to any intervention by the study protocol. Hemodialysis, continuous ambulatory peritoneal dialysis (CAPD), and automated peritoneal dialysis (APD) treatments will continue according to routine clinical practice and the decisions of the treating physicians.

The study will include 100 participants in four groups: 40 patients receiving maintenance hemodialysis, 20 patients receiving CAPD, 20 patients receiving APD, and 20 healthy controls. Dialysis patients will be evaluated at baseline, Month 3, Month 6, and Month 12. Healthy controls will be evaluated at baseline only.

The main objective is to compare patients receiving different dialysis modalities and healthy controls in terms of bone mineral metabolism, systemic inflammation, endothelial dysfunction, arterial stiffness, body composition, functional status, quality of life, pruritus, and pain. Serum sclerostin and fibroblast growth factor-23 (FGF-23) will be evaluated as bone mineral metabolism biomarkers. Serum interleukin-6 (IL-6) and vascular cell adhesion molecule-1 (VCAM-1) will be evaluated as inflammatory and endothelial dysfunction-related biomarkers. These biomarkers will be measured using enzyme-linked immunosorbent assay (ELISA).

For hemodialysis patients, blood samples will be obtained immediately before a mid-week dialysis session through the existing vascular access. For CAPD patients, APD patients, and healthy controls, fasting venous blood samples will be obtained in the morning. Serum samples will be processed and stored according to laboratory procedures until batch analysis.

Arterial stiffness will be assessed using pulse wave velocity (PWV). Body composition and fluid status will be assessed by bioimpedance analysis using the Fresenius Body Composition Monitor (BCM). Body composition parameters will include overhydration, extracellular water to total body water ratio, intracellular water, lean tissue index, body cell mass. Handgrip strength will be measured as a functional parameter.

Patient-reported outcomes will be assessed using the Kidney Disease Quality of Life-36 (KDQOL-36), the Uremic Pruritus in Dialysis Patients (UP-Dial) questionnaire, and the Short-Form McGill Pain Questionnaire (SF-MPQ), as applicable. In healthy controls, kidney disease-specific questionnaire components will not be applied; instead, the 12-Item Short Form Health Survey (SF-12) will be used to assess general health-related quality of life.

The study will also evaluate correlations between molecular biomarkers, instrumental measurements, and clinical scores. Specifically, the relationships between elevated biomarker levels, increased arterial stiffness, altered body composition, lower quality of life, pruritus, and pain burden will be explored.

As an additional objective, objective treatment adherence will be assessed in the APD group using data transferred from home cycler devices to the Sharesource (Baxter/Vantive) cloud-based remote patient monitoring platform. Adherence-related variables will include the percentage of completed sessions, lost dwell time, differences between prescribed and delivered ultrafiltration, and device bypass or manual intervention alarms. Full treatment adherence will be defined as completion of at least 90% of the prescribed dialysis session number and total prescribed dialysis duration.

No additional invasive procedure will be performed other than standard blood sampling for biomarker measurements. Pulse wave velocity and body composition measurements are non-invasive and will be performed using devices used in routine clinical practice.

• Change in Pulse Wave Velocity (PWV) Measured in m/s [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 Overhydration (OH) Measured by Body Composition Monitor [Time frame: 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 Extracellular Water to Total Body Water Ratio (ECW/TBW) [Time frame: 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 Intracellular Water (ICW) Measured by Body Composition Monitor [Time frame: 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 Lean Tissue Index (LTI) Measured by Body Composition Monitor [Time frame: 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 Body Cell Mass Measured by Body Composition Monitor [Time frame: 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.]