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

Brief Summary

Official Title: “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

  • Study Type: Observational
  • Study Design: Observational Model: Case-Crossover, Time Perspective: Prospective
  • Study Primary Completion Date: January 2011

Detailed Clinical Trial 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Clearance for urea, phosphate, beta-2-microglobulin blood cell drop, complement factor C5a, TAT
    • Time Frame: January 2011
      Safety Issue?: Yes

Secondary Measures

  • General survey of the dialysis treatments
    • Time Frame: January 2011
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Praxisverbund Dialyse und Apherese
  • Provider of Information About this Clinical Study
    • Dr. Peter Ahrenholz, BioArtProducts GmbH, Rostock, Germany
  • Overall Official(s)
    • Roland E Winkler, PhD, Study Director, Praxisverbund fuer Dialyse und Apherese Rostock

Source

Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01273870