The clinical investigation will be performed to generate clinical data on clearances and removal rates for ß2-microglobulin and other uremic toxins and on clinical adverse events of the modified polysulfone membrane to fulfil obligations to follow the FX P600 dialyzer in the market.
The primary objective of this study is to test whether the FX P600 is non-inferior to the Xevonta Hi 15 dialyzer and the Elisio 150H dialyzer in removing β2-microglobulin related to the albumin removal into the dialysate during high volume online hemodiafiltration. The secondary objective of this study is to compare the FX P600 dialyzer with the comparator dialyzers with regard to their efficacies in removing other performance variables (see below). Furthermore, the safety of the FX P600 will be investigated by collecting and analyzing clinical adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Three consecutive treatment weeks and one follow-up week per patient. Each treatment week includes three hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Xevonta Hi 15 (B. Braun) and comparator Elisio 150H (Nipro)
Diakonissenkrankenhaus Flensburg
Flensburg, Germany
PHV-Dialysezentrum Goslar
Goslar, Germany
Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
Hanover, Germany
PHV Dialysezentrum Kiel
Kiel, Germany
Removal rate of β2-microglobulin
Removal rate of β2-microglobulin in Plasma related to the albumin removal into the dialysate
Time frame: t=240 minutes of HDF
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