Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers
End Stage Renal Failure on Dialysis
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Prospective
|Official Title:||Post Marketing Surveillance Investigating Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers|
- Clearance for urea, phosphate, beta-2-microglobulin blood cell drop, complement factor C5a, TAT [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]
- General survey of the dialysis treatments [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]Registration of adverse effects of the dialysis treatments
|Study Start Date:||December 2010|
|Study Completion Date:||February 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
The Xenium+ is a new high flux dialyzer made from Polynephron membrane designed and manufactured by the Nipro Company in Japan. This dialyzer has been subjected to in-vitro testing, and all legally required biological safety tests have been conducted and CE-mark was granted in June 2010. Xenium+ has the same Polynephron membrane as the Xenium family of dialyzers which has been available commercially globally for approximately three years. Clinical evaluations have been completed with the Polynephron membrane within the last three years. The improvement in the Xenium+ line is that the casing is now made from polypropylene.
The aim of the dialyzer evaluation is to compare performance characteristics and hemocompatibility of the Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux dialyzers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273870
|Study Director:||Roland E Winkler, PhD||Praxisverbund fuer Dialyse und Apherese Rostock|