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

NCT07685223 | Not Yet Recruiting

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

Brief 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); Chronic Kidney Disease Mineral and Bone Disorder; Hemodialysis

Keywords

End-Stage Kidney Disease; High-Flux Hemodialysis; Medium Cut-Off Membrane; Pulse Wave Velocity; Body Composition Monitor; Handgrip Strength; FGF-23; Sclerostin; CKD-MBD

Outcome Measures

Primary Outcomes (2)

• Change in Serum Fibroblast Growth Factor-23 (FGF-23)

  Change in serum fibroblast growth factor-23 (FGF-23) concentrations during treatment with medium cut-off and high-flux hemodialysis membranes. Serum FGF-23 levels will be measured using ELISA and compared between treatment periods.

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

• Change in Serum Sclerostin

  Change in serum sclerostin concentrations during treatment with medium cut-off and high-flux hemodialysis membranes. Serum sclerostin levels will be measured using ELISA and compared between treatment periods.

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

Secondary Outcomes (10)

• Change in Pulse Wave Velocity (PWV) Measured in m/s

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

• Change in Handgrip Strength Measured by Hand Dynamometer

  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. Serum fibroblast growth factor-23 (FGF-23), sclerostin, pulse wave velocity (PWV), body composition parameters, handgrip strength, and patient-reported outcomes will be assessed 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. Serum fibroblast growth factor-23 (FGF-23), sclerostin, pulse wave velocity (PWV), body composition parameters, handgrip strength, and patient-reported outcomes will be assessed 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

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.

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

High-Flux Hemodialysis Membrane DEVICE

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.

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)

• 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 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

• 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 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Chronic Kidney Disease-Mineral and Bone Disorder; Sclerosteosis

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; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

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 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)