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Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration — comPERFORMStud  

End Stage Renal Disease Clinical Trial

Official title:
Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration - comPERFORM Study (Comparative PERFORMance)

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04102280
Study type Interventional
Source Fresenius Medical Care Deutschland GmbH
Contact
Status Completed
Phase N/A
Start date October 29, 2019
Completion date May 26, 2021
View Details
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