[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646983":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":84,"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. Serum fibroblast growth factor-23 (FGF-23), sclerostin, pulse wave velocity (PWV), body composition parameters, handgrip strength, and patient-reported outcomes will be assessed 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. Serum fibroblast growth factor-23 (FGF-23), sclerostin, pulse wave velocity (PWV), body composition parameters, handgrip strength, and patient-reported outcomes will be assessed 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","A medium cut-off (MCO) hemodialysis membrane used during maintenance hemodialysis treatment. Participants assigned to MCO treatment will receive thrice-weekly hemodialysis according to standard clinical practice. The intervention is intended to enhance the removal of middle-molecular-weight solutes and to evaluate its effects on mineral and bone metabolism biomarkers, including fibroblast growth factor-23 (FGF-23) and sclerostin, as well as body composition, vascular stiffness, and patient-reported outcomes.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"High-Flux Hemodialysis Membrane","A conventional high-flux hemodialysis membrane used during maintenance hemodialysis treatment. Participants assigned to high-flux treatment will receive thrice-weekly hemodialysis according to standard clinical practice. This intervention serves as the comparator for evaluating the effects of medium cut-off membranes on mineral and bone metabolism biomarkers, including fibroblast growth factor-23 (FGF-23) and sclerostin, as well as body composition, vascular stiffness, and patient-reported outcomes.",[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","100646983","medium-cut-off-and-high-flux-membranes-on-mineral-and-bone-metabolism-in-hemodialysis-patients-100646983",false,"NCT07685223","Medium Cut-Off and High-Flux Membranes on Mineral and Bone Metabolism in Hemodialysis Patients","Prospective Comparative Evaluation of the Effects of Medium Cut-Off and High-Flux Hemodialysis Membranes on Mineral and Bone Metabolism Biomarkers and Body Composition in Maintenance Hemodialysis Patients","MBD-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","This study aims to compare the effects of medium cut-off (MCO) and high-flux hemodialysis membranes on mineral and bone metabolism biomarkers in patients receiving maintenance hemodialysis. Chronic kidney disease-mineral and bone disorder (CKD-MBD) is characterized by disturbances in biomarkers such as fibroblast growth factor-23 (FGF-23) and sclerostin, which are associated with bone turnover, vascular calcification, and adverse clinical outcomes.\n\nThis is a single-center, prospective, randomized, open-label, two-sequence, two-period crossover clinical study. Thirty adult patients receiving maintenance hemodialysis will be randomized to receive either MCO membrane treatment followed by high-flux membrane treatment or the reverse sequence, with each treatment period lasting three months.\n\nSerum FGF-23 and sclerostin levels will be measured at baseline, Month 3, and Month 6. Additional assessments will include pulse wave velocity (PWV), body composition monitoring (BCM), handgrip strength, health-related quality of life (KDQOL-36), pruritus severity (UP-Dial), and pain assessment (SF-MPQ). The study will evaluate whether MCO membranes provide additional benefits compared with conventional high-flux membranes regarding CKD-MBD-related biomarkers and patient-centered outcomes.",[81,82,83],"End Stage Kidney Disease (ESKD)","Hemodialysis","Chronic Kidney Disease Mineral and Bone Disorder",[85,86,87,88,89,90,91,92,93],"End-Stage Kidney Disease","High-Flux Hemodialysis","Medium Cut-Off Membrane","Pulse Wave Velocity","Body Composition Monitor","Handgrip Strength","FGF-23","Sclerostin","CKD-MBD","NOT_YET_RECRUITING","2026-06-30",{"date":97,"type":98},"2026-07-06","ACTUAL",{"date":100,"type":75},"2026-07",{"date":102,"type":75},"2027-01",{"name":5,"class":6},1]