Study Stopped
Capacity shortage
12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2018
CompletedFirst Posted
Study publicly available on registry
January 31, 2018
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 15, 2020
April 1, 2020
10 months
January 23, 2018
April 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Comparison of predialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).
12 weeks
Comparison of postdialysis mean of middle molecules after 12 weeks (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin).
12 weeks
Secondary Outcomes (7)
Comparison of predialysis mean of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.
12 weeks
Comparison of postdialysis mean of of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks.
12 weeks
Comparison of predialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).
12 weeks
Comparison of postdialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG).
12 weeks
Comparison of pre- and postdialysis mean of all molecules at 0, 4 and 8 weeks.
8 weeks
- +2 more secondary outcomes
Study Arms (2)
MCO-HD
EXPERIMENTALHemodialysis with Medium Cut-Off filter
High-flux HDF
ACTIVE COMPARATORHemodiafiltration with standard high-flux filter
Interventions
Measurements will be done after 0,4,8 and 12 weeks of hemodialysis with Medium Cut-Off filter.
Measurements will be done after 0,4,8 and 12 weeks of hemodiafiltration with standard high-flux filter
Eligibility Criteria
You may qualify if:
- Ongoing HDF treatment (\>3 months)
- Oliguric
- Albumin ≥ 30
- CRP \<15
- No acute myocardial infarction within 3 months.
- Swedish or english speaking.
You may not qualify if:
- \- Not able to understand the study information.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
- Lund Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anders Christensson, MD, PhD
Region Skane, Lund University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2018
First Posted
January 31, 2018
Study Start
February 1, 2019
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
April 15, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share