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Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers

This study has been completed.
Information provided by:
Praxisverbund Dialyse und Apherese Identifier:
First received: December 22, 2010
Last updated: February 1, 2011
Last verified: November 2010
The aim of the dialyzer evaluation is to compare performance characteristics and haemocompatibility of the Baxter Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux dialyzers

End Stage Renal Failure on Dialysis

Study Type: Observational
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

Further study details as provided by Praxisverbund Dialyse und Apherese:

Primary Outcome Measures:
  • Clearance for urea, phosphate, beta-2-microglobulin blood cell drop, complement factor C5a, TAT [ Time Frame: January 2011 ]

Secondary Outcome Measures:
  • General survey of the dialysis treatments [ Time Frame: January 2011 ]
    Registration of adverse effects of the dialysis treatments

Enrollment: 8
Study Start Date: December 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
8 patients will undergo 1 treatment each with the 4 high-flux dialyzer types using a bloodflow of 300 ml/min, dialysate flow 500 ml/min and the dialysis machine Fresenius 5008

Inclusion Criteria:

  • ESRD patients 18 years or older
  • Stable on hemodialysis for more than 3 months
  • An average haematocrit value of 30 % or higher in the last three 3 months
  • Stable vascular access of either a fistula or graft
  • Stable anticoagulation and regimen
  • Stable erythropoiesis-stimulating agent (ESA) regimen for the last three 3 months
  • No active infection
  • Able to sign informed consent and able to participate in the study
  • Medically stable

Exclusion Criteria:

  • Participation in another study which may interfere with the planned study
  • Active infection
  • Medical conditions which may interfere with the study (cardiac, liver disease, hepatitis)
  • Female(s) who are pregnant or planning to be pregnant
  • Problem with or allergy to anticoagulation
  • Central venous catheters
  Contacts and Locations
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Please refer to this study by its identifier: NCT01273870

Sponsors and Collaborators
Praxisverbund Dialyse und Apherese
Study Director: Roland E Winkler, PhD Praxisverbund fuer Dialyse und Apherese Rostock
  More Information

Responsible Party: Dr. Peter Ahrenholz, BioArtProducts GmbH, Rostock, Germany Identifier: NCT01273870     History of Changes
Other Study ID Numbers: PDA-02
Study First Received: December 22, 2010
Last Updated: February 1, 2011

Keywords provided by Praxisverbund Dialyse und Apherese:
blood compatibility

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases processed this record on May 25, 2017