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

This study has been completed.
Sponsor:
Information provided by:
Praxisverbund Dialyse und Apherese
ClinicalTrials.gov Identifier:
NCT01273870
First received: December 22, 2010
Last updated: February 1, 2011
Last verified: November 2010

December 22, 2010
February 1, 2011
December 2010
January 2011   (final data collection date for primary outcome measure)
Clearance for urea, phosphate, beta-2-microglobulin blood cell drop, complement factor C5a, TAT [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]
Performance: clearance for urea, phosphate, beta-2-microglobulin Compatibility: blood cell drop, complement activation factor C5a, TAT [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01273870 on ClinicalTrials.gov Archive Site
General survey of the dialysis treatments [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]
Registration of adverse effects of the dialysis treatments
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Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers
Post Marketing Surveillance Investigating Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers

The aim of the dialyzer evaluation is to compare performance characteristics and haemocompatibility of the Baxter Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux dialyzers

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.

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Non-Probability Sample

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

End Stage Renal Failure on Dialysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
February 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT01273870
PDA-02
No
Dr. Peter Ahrenholz, BioArtProducts GmbH, Rostock, Germany
Praxisverbund Dialyse und Apherese
Not Provided
Study Director: Roland E Winkler, PhD Praxisverbund fuer Dialyse und Apherese Rostock
Praxisverbund Dialyse und Apherese
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP