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

Starting soon · Not applicable

Conditions studied: End Stage Kidney Disease (ESKD), Hemodialysis, Chronic Kidney Disease Mineral and Bone Disorder

In brief

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.

Key facts

Study ID

NCT07685223

Run by

Gazi University

People needed

30

Starts

2026-07-01

Expected to finish

2027-01-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Gazi University Faculty of Medicine, Department of Nephrology, Hemodialysis Unit — Ankara, Ankara, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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