[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646683":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":21,"locations":27,"responsibleParty":45,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":10,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":63,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":81,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Gazi University","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"Maintenance Hemodialysis",null,"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.",{"label":13,"type":10,"description":14,"interventionNames":10},"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.",{"label":16,"type":10,"description":17,"interventionNames":10},"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.",{"label":19,"type":10,"description":20,"interventionNames":10},"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.",[22],{"name":23,"role":24,"phone":25,"phoneExt":10,"email":26},"Veysel Baran Tomar, M.D.","CONTACT","+905334133253","veyselbarantomar@gazi.edu.tr",[28],{"facility":29,"status":10,"city":30,"state":30,"zip":31,"country":32,"countryCode":10,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Gazi University Faculty of Medicine, Department of Nephrology","Ankara","06500","Turkey (Türkiye)",{"type":34,"coordinates":35},"Point",[36,37],32.85427,39.91987,{"lat":37,"lon":36},[40,41],{"name":23,"role":24,"phone":25,"phoneExt":10,"email":26},{"name":42,"role":24,"phone":43,"phoneExt":10,"email":44},"Omer Faruk Akcay, Associate Professor","+905546992867","omerfarukakcay@gazi.edu.tr",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Veysel Baran TOMAR","Principal Investigator","100646683","cardiovascular-and-bone-mineral-markers-in-dialysis-patients-and-healthy-controls-100646683",false,"NCT07686978","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","Inclusion Criteria:\n\n* Age 18 to 80 years.\n* For dialysis cohorts: diagnosis of end-stage kidney disease and receiving maintenance hemodialysis or peritoneal dialysis.\n* For dialysis cohorts: receiving regular hemodialysis, continuous ambulatory peritoneal dialysis, or automated peritoneal dialysis for at least 6 months.\n* For healthy controls: no known kidney disease, with estimated glomerular filtration rate greater than 90 mL\u002Fmin\u002F1.73 m².\n* For healthy controls: no known systemic inflammatory disease or active malignancy.\n* Able to comply with planned study procedures, including pulse wave velocity measurement, Body Composition Monitor assessment, questionnaires, and biomarker measurements.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Inability to comply with study measurements or questionnaire assessments.\n* Refusal or inability to provide written informed consent.\n* Age younger than 18 years or older than 80 years.\n* Acute infection.\n* Recent major surgical intervention.\n* Active malignancy.\n* Terminal illness with limited life expectancy.\n* Mental, cognitive, physical, or clinical condition preventing participation in study procedures.",true,"ALL","18 Years","80 Years",{"count":61,"type":62},100,"ESTIMATED","1 Year","OBSERVATIONAL","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.\n\nAdult 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.\n\nSerum 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.\n\nThe 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\u002FVantive) cloud-based remote patient monitoring platform.",[67,68,69],"End-Stage Kidney Disease (ESKD)","Hemodialysis","Peritoneal Dialysis (PD)",[68,13,16,71,72,73,74,75,76,77,78,79,80],"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","NOT_YET_RECRUITING","2026-06-30",{"date":84,"type":85},"2026-07-07","ACTUAL",{"date":87,"type":62},"2026-07",{"date":89,"type":62},"2027-07",{"name":5,"class":6},1]