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

NCT ID: NCT01273870

Last Updated: 2011-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-02-28

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.

Conditions

End Stage Renal Failure on Dialysis

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Praxisverbund Dialyse und Apherese

OTHER

Sponsor Role: lead

Responsible Party

BioArtProducts GmbH, Rostock, Germany

Principal Investigators

Roland E Winkler, PhD

Role: STUDY_DIRECTOR

Praxisverbund fuer Dialyse und Apherese Rostock

Other Identifiers

PDA-02

Identifier Type: -

Identifier Source: org_study_id