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Completed

NCT Number: NCT03437538

Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter

The Medium Cut-Off dialysis (MCO) membrane has been developed to improve middle molecule removal compared to standard high-flux dialysis filters.

The major aim of this study is to compare the reduction ratio of middle molecules, during a single hemodialysis session with MCO-filter, compared to hemodiafiltration (HDF) with standard high-flux filter.

Secondary aims are to compare the reduction ratio of small and large molecules between the treatments.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skane University Hospital

Malmö, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ongoing HDF treatment
  • CRP <30
  • No Acute Myocardial Infarction within 3 months.

Exclusion criteria

  • Not able to understand the study information.

Treatment and study plan

MCO-HD

Device

Measurements will be done during a single hemodialysis session with Medium Cut-Off filter

High-flux HDF

Device

Measurements will be done during a single hemodiafiltration session with standard high-flux filter

Primary outcomes

  1. Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)

    Time frame: 4 hours

    Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%

  2. Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)

    Time frame: 30 minutes

    Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.

  3. Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)

    Time frame: 60 minutes

    Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.

  4. Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)

    Time frame: 120 minutes

    Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.

  5. Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)

    Time frame: 240 minutes

    Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.

Secondary outcomes

  1. RR of large molecules (Albumin, Transferrin, IgG)

    Time frame: 4 hours

    Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%

  2. RR of small molecules (Urea, Phosphate, Creatinine)

    Time frame: 4 hours

    Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%

  3. Number of Adverse Events

    Time frame: 4 hours

    Number of adverse events during a 4h dialysis session

  4. Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)

    Time frame: 30 minutes

    Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.

  5. Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)

    Time frame: 60 minutes

    Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.

  6. Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)

    Time frame: 120 minutes

    Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.

  7. Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)

    Time frame: 240 minutes

    Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.

  8. Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)

    Time frame: 30 minutes

    Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.

  9. Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)

    Time frame: 60 minutes

    Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.

  10. Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)

    Time frame: 120 minutes

    Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.

  11. Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)

    Time frame: 240 minutes

    Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University

Registry information

Official study title

Reduction Ratio and Clearance of Middle Molecules During a Single Hemodialysis Session With Medium Cut-Off (MCO) Filter Compared to Hemodiafiltration (HDF) With Standard High-flux Filter

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2018
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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