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12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.

Primary Purpose

Chronic Kidney Diseases, Uremia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MCO-HD
high-flux HDF
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Dialysis, MCO, Middle molecules

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ongoing HDF treatment (>3 months)
  • Oliguric
  • Albumin ≥ 30
  • CRP <15
  • No acute myocardial infarction within 3 months.
  • Swedish or english speaking.

Exclusion Criteria:

- Not able to understand the study information.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MCO-HD

    High-flux HDF

    Arm Description

    Hemodialysis with Medium Cut-Off filter

    Hemodiafiltration with standard high-flux filter

    Outcomes

    Primary Outcome Measures

    Comparison of predialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).
    Comparison of postdialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).

    Secondary Outcome Measures

    Comparison of predialysis mean of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.
    Comparison of postdialysis mean of of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.
    Comparison of predialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).
    Comparison of postdialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).
    Comparison of pre- and postdialysis mean of all molecules at 0, 4 and 8 weeks.
    Comparison of number of adverse effects during the study period.
    Comparison of mean nPCR after 12 weeks.

    Full Information

    First Posted
    January 23, 2018
    Last Updated
    April 14, 2020
    Sponsor
    Region Skane
    Collaborators
    Lund University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03416192
    Brief Title
    12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.
    Official Title
    12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Capacity shortage
    Study Start Date
    February 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Region Skane
    Collaborators
    Lund University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The medium cut-off dialysis (MCO) membrane has been developed to improve middle molecule removal compared to standard high-flux dialysis filters. The aim of this study is to compare levels of middle molecules after 12 weeks of MCO hemodialysis, compared to 12 weeks of hemodiafiltration using standard high-flux filter.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Diseases, Uremia
    Keywords
    Dialysis, MCO, Middle molecules

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MCO-HD
    Arm Type
    Experimental
    Arm Description
    Hemodialysis with Medium Cut-Off filter
    Arm Title
    High-flux HDF
    Arm Type
    Active Comparator
    Arm Description
    Hemodiafiltration with standard high-flux filter
    Intervention Type
    Device
    Intervention Name(s)
    MCO-HD
    Intervention Description
    Measurements will be done after 0,4,8 and 12 weeks of hemodialysis with Medium Cut-Off filter.
    Intervention Type
    Device
    Intervention Name(s)
    high-flux HDF
    Intervention Description
    Measurements will be done after 0,4,8 and 12 weeks of hemodiafiltration with standard high-flux filter
    Primary Outcome Measure Information:
    Title
    Comparison of predialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).
    Time Frame
    12 weeks
    Title
    Comparison of postdialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Comparison of predialysis mean of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.
    Time Frame
    12 weeks
    Title
    Comparison of postdialysis mean of of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.
    Time Frame
    12 weeks
    Title
    Comparison of predialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).
    Time Frame
    12 weeks
    Title
    Comparison of postdialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).
    Time Frame
    12 weeks
    Title
    Comparison of pre- and postdialysis mean of all molecules at 0, 4 and 8 weeks.
    Time Frame
    8 weeks
    Title
    Comparison of number of adverse effects during the study period.
    Time Frame
    12 weeks
    Title
    Comparison of mean nPCR after 12 weeks.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ongoing HDF treatment (>3 months) Oliguric Albumin ≥ 30 CRP <15 No acute myocardial infarction within 3 months. Swedish or english speaking. Exclusion Criteria: - Not able to understand the study information.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anders Christensson, MD, PhD
    Organizational Affiliation
    Region Skane, Lund University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.

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