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

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

Detailed Description
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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.

Official Title
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Post Marketing Surveillance Investigating Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers

Conditions
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End Stage Renal Failure on Dialysis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, high-flux-dialyzer, performance, blood compatibility