NCT07686978Active, not recruiting
Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
Prospective Comparative Evaluation of the Biochemical and Clinical Effects of Different Dialysis Modalities on Cardiovascular Status and Bone Mineral Metabolism
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 30 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- Jul 2027
- Lead sponsor
- Gazi University
- Diseases
- Chronic kidney disease
- NCT number
- NCT07686978
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Jul 2026 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent major surgical intervention.
Other illness
- Acute infection.
- Active malignancy.
- Terminal illness with limited life expectancy.
- Mental, cognitive, physical, or clinical condition preventing participation in study procedures.
Age
- Age younger than 18 years or older than 80 years.
Other
- Inability to comply with study measurements or questionnaire assessments.
- Refusal or inability to provide written informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gazi University Faculty of Medicine, Department of Nephrology Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.