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

NCT07685223 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-06

No results posted yet for this study

Summary

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.

Conditions

  • End Stage Kidney Disease (ESKD)
  • Hemodialysis
  • Chronic Kidney Disease Mineral and Bone Disorder

Interventions

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.

DEVICE

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.

Sponsors & Collaborators

  • Nipro Medical Corporation

    collaborator INDUSTRY

  • Gazi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07685223 on ClinicalTrials.gov