End-Stage Kidney Disease (ESKD)NCT07686978
Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
An observational study of End-Stage Kidney Disease (ESKD) and Hemodialysis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- End-Stage Kidney Disease (ESKD), Hemodialysis, Peritoneal Dialysis (PD)
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to Jul 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Medicine, Department of Nephrology
Ankara, Ankara, 06500
About this study
Official title: Prospective Comparative Evaluation of the Biochemical and Clinical Effects of Different Dialysis Modalities on Cardiovascular Status and Bone Mineral Metabolism
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.
Read more
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.
Read the detailed description
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.
- 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
- Medical subject headings
- Kidney Failure, Chronic, Sclerosteosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Pulse wave velocity (PWV) will be measured in meters per second (m/s) as a single parameter of arterial stiffness. Changes in PWV over time will be evaluated in dialysis cohorts, and baseline PWV values will be compared between dialysis modality groups and healthy controls.
Measured: 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
Handgrip strength will be measured in kilograms (kg) using a hand dynamometer as a functional parameter. Changes in handgrip strength over time will be evaluated in dialysis cohorts, and baseline handgrip strength values will be compared between dialysis modality groups and healthy controls.
Measured: 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
Health-related quality of life will be evaluated using the Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire in dialysis cohorts. Changes in KDQOL-36 scores over time will be evaluated in hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis cohorts. Higher scores indicate better health-related quality of life and a better outcome.
Measured: 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
Pruritus severity will be evaluated using the Uraemic Pruritus in Dialysis Patients (UP-Dial) scale in dialysis cohorts. The UP-Dial total score ranges from 0 to 56, with higher scores indicating more severe pruritus and a worse outcome.
Measured: 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
Pain will be evaluated using the Short-Form McGill Pain Questionnaire (SF-MPQ) total Pain Rating Index score. The SF-MPQ total Pain Rating Index score is calculated from 15 pain descriptors, each scored from 0 to 3, resulting in a total score range of 0 to 45. Higher scores indicate greater pain severity and a worse outcome. Changes over time will be evaluated in dialysis cohorts, and baseline values will be compared between dialysis modality groups and healthy controls.
Measured: 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
Overhydration (OH) will be measured in liters (L) using the Body Composition Monitor (BCM). Changes in OH over time will be evaluated in dialysis cohorts, and baseline OH values will be compared between dialysis modality groups and healthy controls.
Measured: 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)
The extracellular water to total body water ratio (ECW/TBW) will be assessed using the Body Composition Monitor (BCM). Changes in ECW/TBW over time will be evaluated in dialysis cohorts, and baseline ECW/TBW values will be compared between dialysis modality groups and healthy controls.
Measured: 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
Intracellular water (ICW) will be measured in liters (L) using the Body Composition Monitor (BCM). Changes in ICW over time will be evaluated in dialysis cohorts, and baseline ICW values will be compared between dialysis modality groups and healthy controls.
Measured: 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
Lean tissue index (LTI) will be measured in kg/m² using the Body Composition Monitor (BCM). Changes in LTI over time will be evaluated in dialysis cohorts, and baseline LTI values will be compared between dialysis modality groups and healthy controls.
Measured: 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
Body cell mass will be measured in kilograms (kg) using the Body Composition Monitor (BCM). Changes in body cell mass over time will be evaluated in dialysis cohorts, and baseline body cell mass values will be compared between dialysis modality groups and healthy controls.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End-Stage Kidney Disease (ESKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veysel Baran TOMAR, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686978
- Sponsor's protocol ID
- GAZI-HD-PD-2026
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) are not planned to be shared publicly. The study is a single-center observational study with a limited number of participants, and the dataset may include sensitive clinical, laboratory, questionnaire, and treatment adherence data. All data will be stored in coded form and managed in accordance with institutional policies, ethical requirements, and applicable data protection regulations. De-identified aggregate results may be reported in scientific publications.
Publications
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
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.
PubMed 36970967Yildirim 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.
PubMed 34550262