Comparison of the clinical performance and the hemocompatibility profile of different high-flux dialyzers, all applied during post-dilution online hemodiafiltration
The primary objective of this study is to test whether the hemodialyzer FX CorAL 600 (applied during post-dilution online hemodiafiltration) is non-inferior or superior to the comparator hemodialyzers FX CorDiax 600 and xevonta Hi 15 in removing ß2-microglobulin. The secondary objectives of this study are: * To compare the FX CorAL 600 dialyzer with the comparator hemodialyzers FX CorDiax 600 and xevonta Hi 15 regarding their efficacies in removing other uremic toxins. * To compare the FX CorAL 600 dialyzer with the comparator hemodialyzers FX CorDiax 600 and xevonta Hi 15 regarding their hemocompatibility profiles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Three consecutive treatment periods of four weeks, one last study week where the patient is re-assigned to the same type of dialyzer used before beginning the study and one follow-up week per patient. Each treatment period includes 12 hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX CorAL 600 Fresenius Medical Care, comparator FX CorDiax 600 Fresenius Medical Care and comparator xevonta Hi 15 (B. Braun).
Fresenius Nephrocare Nymburk
Nymburk, Czechia
Fresenius Nephrocare Praha 9 - Vysocany
Prague, Czechia
Diakonissenkrankenhaus Flensburg
Flensburg, Germany
PHV-Dialysezentrum Goslar
Goslar, Germany
Removal rate of β2-microglobulin
Removal rate of β2-microglobulin will be calculated a primary endpoint in blood samples to evaluate the clinical Performance of the dialyzer FXCorAL
Time frame: t=240 minutes of HDF
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Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
Hanover, Germany
PHV Dialysezentrum Kiel
Kiel, Germany
Péterfy II. Dialízis Központ
Budapest, Hungary
Váci Dialízis Központ
Vác, Hungary