Randomized Cross-Over Comparison of Medium Cut-Off and High-Flux Hemodialysis Membranes

NCT07679763 | Not Yet Recruiting

• 1 other identifier: GAZI-HD-MCO-HF-2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Kidney Disease (ESKD); Hemodialysis; Cardiovascular Diseases (CVD); Inflammation

Keywords

End-Stage Kidney Disease; High-Flux Hemodialysis; Medium Cut-Off Membrane; Interleukin-6; VCAM-1; Inflammation; Cardiovascular Function; Pulse Wave Velocity; Body Composition Monitor

Outcome Measures

Primary Outcomes (2)

• 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.

  At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)

• 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.

  At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)

Secondary Outcomes (10)

• Change in Pulse Wave Velocity (PWV)

  At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)

• Change in Handgrip Strength

  At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)

• Change in Kidney Disease Quality of Life-36 (KDQOL-36) Score

  At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)

• Change in UP-Dial Pruritus Score

  At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)

• Change in Short-Form McGill Pain Questionnaire (SF-MPQ) Score

  At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)

Study Arms (2)

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. Clinical, laboratory, and patient-reported outcome assessments will be performed at baseline, Month 3, and Month 6.

Device: Medium Cut-Off Hemodialysis Membrane; Device: High-Flux Hemodialysis Membrane

Sequence B (High-Flux to MCO)

EXPERIMENTAL

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. Clinical, laboratory, and patient-reported outcome assessments will be performed at baseline, Month 3, and Month 6.

Device: Medium Cut-Off Hemodialysis Membrane; Device: High-Flux Hemodialysis Membrane

Interventions

Medium Cut-Off Hemodialysis Membrane DEVICE

Medium 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).

Sequence A (MCO to High-Flux); Sequence B (High-Flux to MCO)

High-Flux Hemodialysis Membrane DEVICE

High-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).

Sequence A (MCO to High-Flux); Sequence B (High-Flux to MCO)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Gazi University: lead
• Nipro Medical Corporation: collaborator

Study Sites (1)

Gazi University Faculty of Medicine, Department of Nephrology, Hemodialysis Unit

Ankara, Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (3)

• Yang J, Ke G, Liao Y, Guo Y, Gao X. Efficacy of medium cut-off dialyzers and comparison with high-flux dialyzers in patients on maintenance hemodialysis: A systematic review and meta-analysis. Ther Apher Dial. 2022 Aug;26(4):756-768. doi: 10.1111/1744-9987.13755. Epub 2021 Dec 4.

  PMID: 34773675 BACKGROUND

• Zickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017.

  PMID: 28085888 BACKGROUND

• Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310.

  PMID: 27587605 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Cardiovascular Diseases; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Veysel Baran Tomar, M.D.

CONTACT

+905334133253; veyselbarantomar@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants, care providers, and investigators are aware of the assigned dialysis membrane. No masking procedures are planned.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized in a 1:1 ratio to one of two treatment sequences. Sequence A will receive medium cut-off (MCO) hemodialysis membranes during the first 3-month treatment period followed by high-flux membranes during the second 3-month treatment period. Sequence B will receive high-flux membranes during the first treatment period followed by MCO membranes during the second treatment period. Clinical and laboratory assessments will be performed at baseline, Month 3, and Month 6.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)