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

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

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.

Study Overview

• Status: Completed
• Conditions: Dialysis; Uremia; Chronic Kidney Failure
• Intervention / Treatment: Device: MCO-HD; Device: High-flux HDF

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden
    • Skåne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Not able to understand the study information.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: First MCO-HD, then High-flux-HDF; 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	Device: MCO-HD; Measurements will be done during a single hemodialysis session with Medium Cut-Off filter; Device: High-flux HDF; Measurements will be done during a single hemodiafiltration session with standard high-flux filter
Active Comparator: First High-flux-HDF, then MCO-HD; 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	Device: MCO-HD; Measurements will be done during a single hemodialysis session with Medium Cut-Off filter; Device: High-flux HDF; Measurements will be done during a single hemodiafiltration session with standard high-flux filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	4 hours
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.	30 minutes
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.	60 minutes
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.	120 minutes
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.	240 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University
• Investigators: Principal Investigator: Anders Christensson, MD, PhD, Region Skane, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Actual): April 16, 2019
• Study Completion (Actual): April 16, 2019

Study Registration Dates

• First Submitted: January 22, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 11, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Dialysis; MCO; Middle molecules; High Retention Onset; Medium Cut-Off
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 2017/830/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No