Randomized Cross-Over Comparison of Medium Cut-Off and High-Flux Hemodialysis Membranes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGazi University
About this trial
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.
The 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.
This 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.
The 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Acute infection at screening or enrollment.
Major surgery within the previous 3 months.
Active malignancy requiring ongoing treatment.
Terminal illness with limited life expectancy.
Trial design
Design model
Crossover
Treatments tested in this trial
Medium Cut-Off Hemodialysis Membrane
DeviceMedium 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).
High-Flux Hemodialysis Membrane
DeviceHigh-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).
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Sequence A (MCO to High-Flux)Experimental treatment 2 interventions
Group B: Sequence B (High-Flux to MCO)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Serum Interleukin-6 (IL-6)
Comparison of serum interleukin-6 (IL-6) concentrations during treatment with medium cut-off and high-flux hemodialysis membranes.
Time frame
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)2
Change in Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)
Comparison of serum vascular cell adhesion molecule-1 (VCAM-1) concentrations during treatment with medium cut-off and high-flux hemodialysis membranes.
Time frame
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)Secondary outcomes
1
Change in Pulse Wave Velocity (PWV)
Assessment of arterial stiffness by pulse wave velocity measurements.
Time frame
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)2
Change in Handgrip Strength
Assessment of physical function using handgrip strength measurement.
Time frame
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)3
Change in Kidney Disease Quality of Life-36 (KDQOL-36) Score
Evaluation of patient-reported quality of life using the KDQOL-36 questionnaire.
Time frame
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)4
Change in UP-Dial Pruritus Score
Evaluation of pruritus severity using the Uraemic Pruritus in Dialysis Patients (UP-Dial) scale. The UP-Dial total score ranges from 0 to 56, with higher scores indicating more severe pruritus and a worse outcome.
Time frame
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Gazi University
Lead sponsor
Nipro Medical Corporation
Collaborator
Source ClinicalTrials.gov
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