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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01273870

Enrollment

Registered

2011-01-11

Start date

2010-12-31

Completion date

2011-02-28

Last updated

2011-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Failure on Dialysis

Keywords

hemodialysis, high-flux-dialyzer, performance, blood compatibility

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
General survey of the dialysis treatments	January 2011	Registration of adverse effects of the dialysis treatments

Outcome results