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

February 1, 2011 updated by: Praxisverbund Dialyse und Apherese

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 Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clearance for urea, phosphate, beta-2-microglobulin blood cell drop, complement factor C5a, TAT
Time Frame: January 2011
January 2011

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General survey of the dialysis treatments
Time Frame: January 2011
Registration of adverse effects of the dialysis treatments
January 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Praxisverbund Dialyse und Apherese

Investigators

  • Study Director: Roland E Winkler, PhD, Praxisverbund fuer Dialyse und Apherese Rostock

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

December 22, 2010

First Submitted That Met QC Criteria

January 10, 2011

First Posted (ESTIMATE)

January 11, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2011

Last Update Submitted That Met QC Criteria

February 1, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDA-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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