Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 28
Summary
- Conditions
- End Stage Renal Disease
- Renal Failure
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Intervention Model: Sequential AssignmentIntervention Model Description: prospective, open, controlled, cross-over (with randomized treatment sequences), interventional, multi-centerMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ?2-microglobulin related to the albumin removal into the dialysate during high volume online hemodiafiltration. The secondary objective of this st...
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 ?2-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.
Tracking Information
- NCT #
- NCT04102280
- Collaborators
- Institut Dr. Schauerte (IDS)
- Investigators
- Principal Investigator: Götz Ehlerding, Dr med Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
Get Well Soon