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Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration — eMPORA II  

End Stage Renal Disease Clinical Trial

Official title:
Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration - eMPORA II Study (Modified POlysulfone membRAne)

Clinical Trial Summary

The clinical Investigation will be performed to compare the safety and clinical performance profile of different hemodialyzers, all applied in on-line postdilution hemodiafiltration

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03611218
Study type Interventional
Source Fresenius Medical Care Deutschland GmbH
Contact
Status Completed
Phase N/A
Start date August 29, 2018
Completion date December 8, 2018
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