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

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

Conditions
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Uremia, Chronic Kidney Diseases

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 (>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.

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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCO-HD<br>Hemodialysis with Medium Cut-Off filter | Device: MCO-HD<br>* Measurements will be done after 0,4,8 and 12 weeks of hemodialysis with Medium Cut-Off filter.<br>Device: high-flux HDF<br>* Measurements will be done after 0,4,8 and 12 weeks of hemodiafiltration with standard high-flux filter<br>|
| Active Comparator: High-flux HDF<br>Hemodiafiltration with standard high-flux filter | Device: MCO-HD<br>* Measurements will be done after 0,4,8 and 12 weeks of hemodialysis with Medium Cut-Off filter.<br>Device: high-flux HDF<br>* Measurements will be done after 0,4,8 and 12 weeks of hemodiafiltration with standard high-flux filter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Comparison of number of adverse effects during the study period. |  | 12 weeks | 
| Comparison of mean nPCR after 12 weeks. |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCO, Dialysis, Middle molecules