Medium Cut-Off and High-Flux Membranes on Mineral and Bone Metabolism in Hemodialysis Patients

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. This 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. Serum 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.

Inclusion Criteria: * Age 18 to 80 years. * Receiving maintenance hemodialysis for at least 6 months. * Clinically stable and receiving thrice-weekly hemodialysis. * Able to comply with study procedures, questionnaires, and scheduled assessments. * Able and willing to provide written informed consent. Exclusion Criteria: * Acute infection at screening or enrollment. * Major surgery within the previous 3 months. * Active malignancy requiring ongoing treatment. * Terminal illness with limited life expectancy. * Physical or cognitive impairment preventing completion of study procedures or questionnaires. * Inability or unwillingness to provide written informed consent.