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Clinical Trials/NCT03437538
NCT03437538
Completed
Not Applicable

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

Region Skane1 site in 1 country18 target enrollmentMay 21, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Failure
Sponsor
Region Skane
Enrollment
18
Locations
1
Primary Endpoint
Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 21, 2018
End Date
April 16, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not able to understand the study information.

Outcomes

Primary Outcomes

Reduction ratio (RR) of middle molecules (Beta-2-microglobulin, Cystatin C, Myoglobin, Beta-Trace Protein, Troponin T, Prealbumin)

Time Frame: 4 hours

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)

Time Frame: 240 minutes

Instantaneous arteriovenous clearance (ml/min) at 240 minutes of dialysis.

Secondary Outcomes

  • Number of Adverse Events(4 hours)
  • RR of large molecules (Albumin, Transferrin, IgG)(4 hours)
  • RR of small molecules (Urea, Phosphate, Creatinine)(4 hours)
  • Instantaneous arteriovenous clearance of large molecules (Albumin, Transferrin, IgG)(240 minutes)
  • Instantaneous arteriovenous clearance of small molecules (Urea, Phosphate, Creatinine)(240 minutes)

Study Sites (1)

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