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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Kidney Failure, Uremia, Dialysis

Intervention / Treatment
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* Device: MCO-HD
* Device: High-flux HDF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ongoing HDF treatment CRP <30 No Acute Myocardial Infarction within 3 months. Exclusion Criteria: Not able to understand the study information.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, MCO, Middle molecules, High Retention Onset, Medium Cut-Off