The clinical Investigation will be performed to compare the safety and clinical performance profile of different hemodialyzers, all applied in on-line postdilution hemodiafiltration
The primary objective of this study is to test whether the new FX P600 (applied during post-dilution online HDF) is non-inferior to two comparator dialyzers (Sureflux-17UX (Nipro) and Polyflux 170 H (Baxter/Gambro) in removing β2-microglobulin. The secondary objective is to exploratively compare the efficacy in removing other uremic solutes between the new FX P600 and the Sureflux-17UX as well as the Polyflux 170 H membranes. Additionally, the safety of the FX P600 dialyzer with a modified polysulfone membrane will be investigated.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Three hemodiafiltration sessions assigned to one type of dialyzer FX P600 (Fresenius Medical Care), comparator Sureflux-17UX and comparator Polyflux 170 H
Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
Hanover, Lower Saxony, Germany
Diakonissenkrankenhaus Flensburg
Flensburg, Germany
Georg-Haas-Dialysezentrum der PHV
Giessen, Germany
PHV-Dialysezentrum Goslar
Goslar, Germany
Removal rate of β2-microglobulin
Removal rate of β2-microglobulin will be calculated as primary endpoint in blood samples to evaluate the clinical performance of the new FX P600 dialyzer.
Time frame: t=240 minutes of HDF
Clearance of β2-microglobulin
Time frame: t=60 minutes of HDF
Removal rate of α1-microglobulin
Time frame: t=240 minutes of HDF
Clearance of α1-microglobulin
Time frame: t= 60 minutes of HDF
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PHV Dialysezentrum Kiel
Kiel, Germany
PHV-Dialysezentrum Lauterbach
Lauterbach, Germany