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

Primary Purpose

Chronic Kidney Failure, Uremia, Dialysis

Status
Completed
Phase
Not Applicable
Locations
Sweden
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 Failure focused on measuring Dialysis, MCO, Middle molecules, High Retention Onset, Medium Cut-Off

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Not able to understand the study information.

Sites / Locations

  • Skane University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

First MCO-HD, then High-flux-HDF

First High-flux-HDF, then MCO-HD

Arm Description

Participants with ongoing HDF-treatments will have measurements during an intervention with a 4h dialysis with MCO-HD, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during a 4h dialysis with High-flux-HDF

Participants with ongoing HDF-treatments will have measurements during a 4h dialysis with High-flux-HDF, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during an intervention with a 4h dialysis with MCO-HD

Outcomes

Primary Outcome Measures

Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.

Secondary Outcome Measures

RR of large molecules (Albumin, Transferrin, IgG)
Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%
RR of small molecules (Urea, Phosphate, Creatinine)
Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%
Number of Adverse Events
Number of adverse events during a 4h dialysis session
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.

Full Information

First Posted
January 22, 2018
Last Updated
November 11, 2019
Sponsor
Region Skane
Collaborators
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT03437538
Brief Title
Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
April 16, 2019 (Actual)
Study Completion Date
April 16, 2019 (Actual)

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Failure, Uremia, Dialysis
Keywords
Dialysis, MCO, Middle molecules, High Retention Onset, Medium Cut-Off

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
First MCO-HD, then High-flux-HDF
Arm Type
Active Comparator
Arm Description
Participants with ongoing HDF-treatments will have measurements during an intervention with a 4h dialysis with MCO-HD, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during a 4h dialysis with High-flux-HDF
Arm Title
First High-flux-HDF, then MCO-HD
Arm Type
Active Comparator
Arm Description
Participants with ongoing HDF-treatments will have measurements during a 4h dialysis with High-flux-HDF, followed by 2 weeks of washout with ordinary HDF, thereafter measurements during an intervention with a 4h dialysis with MCO-HD
Intervention Type
Device
Intervention Name(s)
MCO-HD
Intervention Description
Measurements will be done during a single hemodialysis session with Medium Cut-Off filter
Intervention Type
Device
Intervention Name(s)
High-flux HDF
Intervention Description
Measurements will be done during a single hemodiafiltration session with standard high-flux filter
Primary Outcome Measure Information:
Title
Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Description
Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%
Time Frame
4 hours
Title
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Description
Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
Time Frame
30 minutes
Title
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Description
Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.
Time Frame
60 minutes
Title
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Description
Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.
Time Frame
120 minutes
Title
Instantaneous arteriovenous clearance of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Description
Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.
Time Frame
240 minutes
Secondary Outcome Measure Information:
Title
RR of large molecules (Albumin, Transferrin, IgG)
Description
Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%
Time Frame
4 hours
Title
RR of small molecules (Urea, Phosphate, Creatinine)
Description
Reduction ratio during a 4h dialysis session. (Predialysis concentration - Postdialysis concentration)/Predialysis concentration*100%
Time Frame
4 hours
Title
Number of Adverse Events
Description
Number of adverse events during a 4h dialysis session
Time Frame
4 hours
Title
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Description
Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
Time Frame
30 minutes
Title
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Description
Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.
Time Frame
60 minutes
Title
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Description
Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.
Time Frame
120 minutes
Title
Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)
Description
Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.
Time Frame
240 minutes
Title
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Description
Instantaneous arteriovenous clearance (ml/min) at 30 minutes of dialysis.
Time Frame
30 minutes
Title
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Description
Instantaneous arteriovenous clearance (ml/min) at 60 minutes of dialysis.
Time Frame
60 minutes
Title
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Description
Instantaneous arteriovenous clearance (ml/min) at 120 minutes of dialysis.
Time Frame
120 minutes
Title
Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)
Description
Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.
Time Frame
240 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ongoing HDF treatment CRP <30 No Acute Myocardial Infarction within 3 months. 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
Facility Information:
Facility Name
Skane University Hospital
City
Malmö
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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