Modulation of Inflammation by Medium Cut Off Membranes

Study Overview
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Brief Summary
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This study examines whether medium-cut off dialysis results in improved blood purification of large middle molecules e.g. inflammatory molecules compared to hemodialysis (HD) treatments with conventional high-flux dialyzers.

Detailed Description
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Cardiovascular events and sepsis remain the leading causes of mortality in patients on maintenance hemodialysis. Thus expectancy of life for these patients is comparable to the prognosis of metastasized cancer. So far the exact mechanisms causing excess mortality in hemodialysis patients remain elusive, but chronic inflammation seems to play a central role in the pathogenesis of cardiovascular disease in HD patients. Keeping this in mind the Theranova medium-cut off membrane, with its ability to clear middle molecules (0,5-50 kDa), seems suitable to further improve clearance of inflammatory mediators as the non-protein bound inflammatory mediators lie within the cut off range of this membrane. The investigators designed this study to get information on the changes in the inflammatory milieu in dialysis patients when using medium-cut off membranes which are know to significantly reduce cytokines compared to standard high-flux dialyzers.

Official Title
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Medium-term Modulation of the Inflammatory Profile by Medium-cut Off Membranes in Patients With End Stage Renal Disease

Conditions
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Cardiovascular Diseases, End Stage Renal Disease

Intervention / Treatment
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* Device: Medium cut off dialysis
* Device: Standard High Flux Dialyzer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: time since initiation of dialysis > 3 months age > 18 years Exclusion Criteria: time since initiation of dialysis < 3 months age < 18 years ongoing acute or chronic infection/malignoma, because this will interfere with inflammatory baseline values major surgery less than 2 weeks before inclusion in the study pregnancy mental illness lack of written and informed consent

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
Interventional Model Description: Medium cut off Dialyzer compared with standard of care High-Flux Dialyzer (Fx Cor Diax 60®). No others changes in our standard of care maintenance dialysis is planned, dialysis specific parameters such as blood flow will be kept unchanged during the study period).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCO Dialysis<br>Theranova Dialyzer | Device: Medium cut off dialysis<br>* Hemodialysis<br>* Other names: Theranova Dialyzer;|
| Active Comparator: Standard High Flux Dialysis<br>Standard High Flux Dialyzer | Device: Standard High Flux Dialyzer<br>* Hemodialysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inflammation | change of inflammatory score (inflammatory score is derived from multiple biomarkers) | 240 days (cross-over design, multiple measurements) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in calcification status | calcification score derived from several pro- and anticalcifying biomarkers | 240 days (cross-over design, multiple measurements) | 
| change in calcification propensity | this values measures the resistence of serum to a calcification stimulus | 240 days (cross-over design, multiple measurements) |