Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01273870|
Recruitment Status : Completed
First Posted : January 11, 2011
Last Update Posted : February 2, 2011
|Condition or disease|
|End Stage Renal Failure on Dialysis|
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.
|Study Type :||Observational|
|Actual Enrollment :||8 participants|
|Official Title:||Post Marketing Surveillance Investigating Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||February 2011|
- Clearance for urea, phosphate, beta-2-microglobulin blood cell drop, complement factor C5a, TAT [ Time Frame: January 2011 ]
- General survey of the dialysis treatments [ Time Frame: January 2011 ]Registration of adverse effects of the dialysis treatments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273870
|Study Director:||Roland E Winkler, PhD||Praxisverbund fuer Dialyse und Apherese Rostock|