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Medium Cut-Off and High-Flux Membranes on Mineral and Bone Metabolism in Hemodialysis Patients (MBD-HD)

30. Juni 2026 aktualisiert von: Veysel Baran TOMAR, Gazi University

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

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Türkei (türkiye)
    • Ankara
      • Ankara, Ankara, Türkei (türkiye), 06500
        • Gazi University Faculty of Medicine, Department of Nephrology, Hemodialysis Unit
        • Kontakt:
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Sequence A (MCO to High-Flux)
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.
Gerät: 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.
Gerät: 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.
Experimental: Sequence B (High-Flux to MCO)
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.
Gerät: 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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Serum Fibroblast Growth Factor-23 (FGF-23)
Zeitfenster: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
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
Zeitfenster: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Kidney Disease Quality of Life-36 (KDQOL-36) Score
Zeitfenster: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Evaluation of patient-reported quality of life using the KDQOL-36 questionnaire.
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in UP-Dial Pruritus Score
Zeitfenster: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
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.
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Short-Form McGill Pain Questionnaire (SF-MPQ) Score
Zeitfenster: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Evaluation of pain using the Short-Form McGill Pain Questionnaire (SF-MPQ) total Pain Rating Index score. The SF-MPQ total Pain Rating Index score is calculated from 15 pain descriptors, each scored from 0 to 3, resulting in a total score range of 0 to 45. Higher scores indicate greater pain severity and a worse outcome.
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Overhydration (OH)
Zeitfenster: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Assessment of overhydration (OH, L) measured using the Body Composition Monitor (BCM).
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Extracellular Water to Total Body Water Ratio (ECW/TBW)
Zeitfenster: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Assessment of the extracellular water to total body water ratio (ECW/TBW) using the Body Composition Monitor (BCM).
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Intracellular Water (ICW)
Zeitfenster: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Assessment of intracellular water (ICW, L) using the Body Composition Monitor (BCM).
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Lean Tissue Index (LTI)
Zeitfenster: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Assessment of lean tissue index (LTI, kg/m²) using the Body Composition Monitor (BCM).
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Body Cell Mass (BCM)
Zeitfenster: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Assessment of body cell mass (BCM, kg) using the Body Composition Monitor.
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Pulse Wave Velocity (PWV) Measured in m/s
Zeitfenster: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Pulse wave velocity (PWV) will be measured in meters per second (m/s) as a single parameter of arterial stiffness. Change in PWV from baseline to Month 3 and Month 6 will be compared between medium cut-off and high-flux hemodialysis membrane treatment periods.
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Handgrip Strength Measured by Hand Dynamometer
Zeitfenster: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Handgrip strength will be measured in kilograms (kg) using a hand dynamometer. The same prespecified measurement method will be used at each study visit. Change in handgrip strength from baseline to Month 3 and Month 6 will be compared between medium cut-off and high-flux hemodialysis membrane treatment periods.
At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Gazi University

Mitarbeiter

Nipro Medical Corporation

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

24. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Juni 2026

Zuerst gepostet (Tatsächlich)

6. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GAZI-HD-MCO-MBD-2026

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data (IPD) are not planned to be shared publicly. The study involves a limited number of participants from a single center, and data will be retained and managed in accordance with institutional policies, ethical requirements, and applicable data protection regulations.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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