[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645108":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":54,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":94,"whyStopped":25,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Gazi University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence A (MCO to High-Flux)","EXPERIMENTAL","Participants randomized to Sequence A will receive medium cut-off (MCO) hemodialysis membranes during Period 1 (Months 0-3), followed by high-flux hemodialysis membranes during Period 2 (Months 3-6). Hemodialysis will be performed three times weekly according to standard clinical practice. Clinical, laboratory, and patient-reported outcome assessments will be performed at baseline, Month 3, and Month 6.",[13,14],"Device: Medium Cut-Off Hemodialysis Membrane","Device: High-Flux Hemodialysis Membrane",{"label":16,"type":10,"description":17,"interventionNames":18},"Sequence B (High-Flux to MCO)","Participants randomized to Sequence B will receive high-flux hemodialysis membranes during Period 1 (Months 0-3), followed by medium cut-off (MCO) hemodialysis membranes during Period 2 (Months 3-6). Hemodialysis will be performed three times weekly according to standard clinical practice. Clinical, laboratory, and patient-reported outcome assessments will be performed at baseline, Month 3, and Month 6.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Medium Cut-Off Hemodialysis Membrane","Medium cut-off (MCO) hemodialysis membrane used as part of routine maintenance hemodialysis treatment. MCO membranes are designed to enhance the clearance of larger middle-molecular-weight uremic toxins while maintaining clinically acceptable albumin retention. Participants assigned to MCO treatment periods will receive thrice-weekly hemodialysis according to standard clinical practice. In this study, MCO treatment will be delivered using the ELISIO™ MCO series (Nipro).",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"High-Flux Hemodialysis Membrane","High-flux hemodialysis membrane used as part of routine maintenance hemodialysis treatment. High-flux membranes represent the current standard dialysis technology and provide effective clearance of small solutes and selected middle molecules. Participants assigned to high-flux treatment periods will receive thrice-weekly hemodialysis according to standard clinical practice. In this study, high-flux treatment will be delivered using the ELISIO™ HF series (Nipro).",[9,16],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Veysel Baran Tomar, M.D.","CONTACT","+905334133253","veyselbarantomar@gazi.edu.tr",[37],{"facility":38,"status":25,"city":39,"state":39,"zip":40,"country":41,"countryCode":25,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Gazi University Faculty of Medicine, Department of Nephrology, Hemodialysis Unit","Ankara","06500","Turkey (Türkiye)",{"type":43,"coordinates":44},"Point",[45,46],32.85427,39.91987,{"lat":46,"lon":45},[49,50],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"name":51,"role":33,"phone":52,"phoneExt":25,"email":53},"Omer Faruk Akcay, Associate Professor","+905546992867","omerfarukakcay@gazi.edu.tr",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Veysel Baran TOMAR","Principal Investigator",[59],{"name":60,"class":61},"Nipro Medical Corporation","INDUSTRY","100645108","randomized-cross-over-comparison-of-medium-cut-off-and-high-flux-hemodialysis-membranes-100645108",false,"NCT07679763","Randomized Cross-Over Comparison of Medium Cut-Off and High-Flux Hemodialysis Membranes","Randomized Cross-Over Evaluation of Medium Cut-Off and High-Flux Hemodialysis Membranes on Inflammation and Cardiovascular Function in Maintenance Hemodialysis Patients","MCO-HD","Inclusion Criteria:\n\n* Age 18 to 80 years.\n* Receiving maintenance hemodialysis for at least 6 months.\n* Clinically stable and receiving thrice-weekly hemodialysis.\n* Able to comply with study procedures, questionnaires, and scheduled assessments.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Acute infection at screening or enrollment.\n* Major surgery within the previous 3 months.\n* Active malignancy requiring ongoing treatment.\n* Terminal illness with limited life expectancy.\n* Physical or cognitive impairment preventing completion of study procedures or questionnaires.\n* Inability or unwillingness to provide written informed consent.","ALL","18 Years","80 Years",{"count":74,"type":75},30,"ESTIMATED","INTERVENTIONAL",[78],"NA","Patients receiving maintenance hemodialysis are at increased risk of cardiovascular disease, chronic inflammation, endothelial dysfunction, and impaired quality of life. Medium cut-Off (MCO) hemodialysis membranes have been developed to enhance the removal of middle-molecular-weight uremic toxins compared with conventional high-flux membranes, which may improve inflammatory status and cardiovascular health.\n\nThe aim of this study is to compare the effects of MCO and high-flux hemodialysis membranes on inflammatory biomarkers and cardiovascular function in adult patients receiving maintenance hemodialysis. The primary outcomes are changes in serum interleukin-6 (IL-6) and vascular cell adhesion molecule-1 (VCAM-1) levels. Secondary outcomes include arterial stiffness assessed by pulse wave velocity (PWV), body composition assessed by Body Composition Monitor (BCM), handgrip strength, and patient-reported outcomes including quality of life, pruritus, and pain scores.\n\nThis is a prospective, randomized, open-label, two-sequence, two-period crossover study conducted at Gazi University Faculty of Medicine. Thirty adult hemodialysis patients will be randomized to one of two treatment sequences. Participants in Sequence A will receive MCO dialysis membranes for the first 3 months followed by high-flux membranes for the next 3 months. Participants in Sequence B will receive high-flux membranes for the first 3 months followed by MCO membranes for the next 3 months. Blood samples and clinical assessments will be performed at baseline, month 3, and month 6.\n\nThe study is expected to provide evidence regarding the effects of different dialysis membrane technologies on inflammation and cardiovascular health and may contribute to optimizing membrane selection in routine hemodialysis practice.",[81,82,83,84],"End Stage Kidney Disease (ESKD)","Hemodialysis","Cardiovascular Diseases (CVD)","Inflammation",[86,87,88,89,90,84,91,92,93],"End-Stage Kidney Disease","High-Flux Hemodialysis","Medium Cut-Off Membrane","Interleukin-6","VCAM-1","Cardiovascular Function","Pulse Wave Velocity","Body Composition Monitor","NOT_YET_RECRUITING","2026-06-30",{"date":97,"type":98},"2026-07-01","ACTUAL",{"date":100,"type":75},"2026-07",{"date":102,"type":75},"2027-01",{"name":5,"class":6},1]