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

Официальное название

Prospective Comparative Evaluation of the Effects of Medium Cut-Off and High-Flux Hemodialysis Membranes on Mineral and Bone Metabolism Biomarkers and Body Composition in Maintenance Hemodialysis Patients

Обзор

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.

Подробное описание

Chronic kidney disease-mineral and bone disorder (CKD-MBD) is a common complication in patients receiving maintenance hemodialysis and is associated with abnormalities in mineral metabolism, bone turnover, vascular calcification, and increased cardiovascular risk. Biomarkers such as fibroblast growth factor-23 (FGF-23) and sclerostin play important roles in the pathophysiology of CKD-MBD and have been associated with adverse clinical outcomes in patients with end-stage kidney disease.

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. Because FGF-23 and sclerostin are relatively large circulating molecules, MCO membranes may provide improved clearance and potentially influence CKD-MBD-related biological pathways.

This study is a single-center, prospective, randomized, open-label, two-sequence, two-period crossover clinical investigation conducted in maintenance hemodialysis patients. Eligible participants will be randomized in a 1:1 ratio to one of two treatment sequences. Sequence A will receive MCO hemodialysis for three months followed by high-flux hemodialysis for three months. Sequence B will receive high-flux hemodialysis for three months followed by MCO hemodialysis for three months.

Assessments will be performed at baseline, Month 3, and Month 6. Primary outcome measures include changes in serum FGF-23 and sclerostin concentrations. Secondary outcome measures include changes in pulse wave velocity (PWV), body composition parameters measured by BCM, handgrip strength, health-related quality of life (KDQOL-36), pruritus severity (UP-Dial), and pain characteristics (SF-MPQ).

Routine laboratory evaluations will be performed according to standard clinical practice. In addition, blood samples will be collected for FGF-23 and sclerostin measurements at each study visit. Safety assessments will include monitoring of adverse events, dialysis-related intolerance, and clinically significant medical events throughout the study period.

The results of this study are expected to provide evidence regarding the effects of MCO membranes on CKD-MBD-related biomarkers and patient-centered outcomes and may contribute to optimizing membrane selection strategies in maintenance hemodialysis practice.

Вмешательства

• Устройство 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-repor
• Устройство 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 outco

Первичные конечные точки

• Change in Serum Fibroblast Growth Factor-23 (FGF-23) [Срок оценки: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)]
• Change in Serum Sclerostin [Срок оценки: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)]

Вторичные конечные точки (10)

• Change in Pulse Wave Velocity (PWV) Measured in m/s [Срок оценки: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)]
• Change in Handgrip Strength Measured by Hand Dynamometer [Срок оценки: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)]
• Change in Kidney Disease Quality of Life-36 (KDQOL-36) Score [Срок оценки: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)]
• Change in UP-Dial Pruritus Score [Срок оценки: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)]
• Change in Short-Form McGill Pain Questionnaire (SF-MPQ) Score [Срок оценки: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)]
• Change in Overhydration (OH) [Срок оценки: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)]
• Change in Extracellular Water to Total Body Water Ratio (ECW/TBW) [Срок оценки: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)]
• Change in Intracellular Water (ICW) [Срок оценки: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)]
• Change in Lean Tissue Index (LTI) [Срок оценки: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)]
• Change in Body Cell Mass (BCM) [Срок оценки: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Gazi University Faculty of Medicine, Department of Nephrology, Hemodialysis Unit — Ankara

Публикации

• Figurek A, Rroji M, Spasovski G. Sclerostin: a new biomarker of CKD-MBD. Int Urol Nephrol. 2020 Jan;52(1):107-113. doi: 10.1007/s11255-019-02290-3. Epub 2019 Oct 14. PMID 31612420
• 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
• Kim HJ, Seong EY, Song SH. Medium cut-off dialyzer improves reduction ratios of large middle molecules associated with vascular calcification. Kidney Res Clin Pract. 2024 Nov;43(6):753-762. doi: 10.23876/j.krcp.23.061. Epub 2024 Jan 25. PMID 38268127

Идентификаторы

NCT: NCT07685223 · GAZI-HD-MCO-MBD-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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