Kidney Insufficiency Clinical Trial
Official title:
Determination of the In-vivo Ultrafiltration Coefficient and Evaluation of Performance, Hemo- and Biocompatibility- and Safety-data of High Flux Hemodialyser Diacap Pro in Patients With End Stage Renal Disease on Chronic Hemodialysis
The main purpose of this study is the determination of the in-vivo ultrafiltration coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription in the United States.
The in-vivo KUF for Diacap Pro High Flux dialysers with the surface sizes of 1.3/ 1.6/ 1.9
sqm will be determined as required by the US guideline "Guidance for the Content of
Premarket Notifications for Conventional and High Permeability Hemodialyzers 1998" for
comparison with the in-vitro KUF data.
Clinical data of at least 12 patients will be collected for determination of the in-vivo KUF
complemented by safety-, performance-data for the removal of small and middle molecular
substances and hemocompatibility data.
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