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Withdrawn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
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Dialysis, MCO, Middle molecules
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.
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
NCT ID
NCT03416192
First Posted
January 23, 2018
Last Updated
April 14, 2020
Sponsor
Region Skane
Collaborators
Lund University
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Withdrawn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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