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

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ClinicalTrials.gov Identifier: NCT03416192
Recruitment Status : Withdrawn (Capacity shortage)
First Posted : January 31, 2018
Last Update Posted : April 15, 2020
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Region Skane

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Uremia Device: MCO-HD Device: high-flux HDF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter.
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: MCO-HD
Hemodialysis with Medium Cut-Off filter
Device: MCO-HD
Measurements will be done after 0,4,8 and 12 weeks of hemodialysis with Medium Cut-Off filter.

Device: high-flux HDF
Measurements will be done after 0,4,8 and 12 weeks of hemodiafiltration with standard high-flux filter

Active Comparator: High-flux HDF
Hemodiafiltration with standard high-flux filter
Device: MCO-HD
Measurements will be done after 0,4,8 and 12 weeks of hemodialysis with Medium Cut-Off filter.

Device: high-flux HDF
Measurements will be done after 0,4,8 and 12 weeks of hemodiafiltration with standard high-flux filter




Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. Comparison of predialysis mean of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks. [ Time Frame: 12 weeks ]
  2. Comparison of postdialysis mean of of small molecules (CRP, Urea, Phosphate and Creatinine) after 12 weeks. [ Time Frame: 12 weeks ]
  3. Comparison of predialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG). [ Time Frame: 12 weeks ]
  4. Comparison of postdialysis mean of large molecules after 12 weeks (Albumin, Transferrin, IgG). [ Time Frame: 12 weeks ]
  5. Comparison of pre- and postdialysis mean of all molecules at 0, 4 and 8 weeks. [ Time Frame: 8 weeks ]
  6. Comparison of number of adverse effects during the study period. [ Time Frame: 12 weeks ]
  7. Comparison of mean nPCR after 12 weeks. [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416192


Sponsors and Collaborators
Region Skane
Lund University
Investigators
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Principal Investigator: Anders Christensson, MD, PhD Region Skane, Lund University
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03416192    
Other Study ID Numbers: 2017/830/2
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Skane:
Dialysis
MCO
Middle molecules
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency