Text Size

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
History of Changes
  Purpose

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


Condition
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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • General survey of the dialysis treatments [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273870

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

No publications provided

Responsible Party: Dr. Peter Ahrenholz, BioArtProducts GmbH, Rostock, Germany
ClinicalTrials.gov Identifier: NCT01273870     History of Changes
Other Study ID Numbers: PDA-02
Study First Received: December 22, 2010
Last Updated: February 1, 2011
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Praxisverbund Dialyse und Apherese:
hemodialysis
high-flux-dialyzer
performance
blood compatibility

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013