Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
Active, not recruitingNCT07686978
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Prospective Comparative Evaluation of the Biochemical and Clinical Effects of Different Dialysis Modalities on Cardiovascular Status and Bone Mineral Metabolism
- Conditions
- End-Stage Kidney Disease (ESKD)
- Hemodialysis
- Peritoneal Dialysis (PD)
- Sponsor
- Gazi University
- Start date
- 2026-07-01
- Primary completion
- 2027-07
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Turkey (Türkiye)
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07686978