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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02964429
Study type Interventional
Source B.Braun Avitum AG
Contact
Status Completed
Phase N/A
Start date November 14, 2016
Completion date December 23, 2016

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