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Search / Trial NCT01273870

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

Launched by PRAXISVERBUND DIALYSE UND APHERESE · Jan 10, 2011

Trial Information

Current as of June 23, 2025

Completed

Keywords

Hemodialysis High Flux Dialyzer Performance Blood Compatibility

ClinConnect Summary

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...

Gender

ALL

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

About Praxisverbund Dialyse Und Apherese

Praxisverbund Dialyse und Apherese is a leading clinical trial sponsor specializing in the fields of nephrology and apheresis therapies. Committed to advancing patient care, the organization focuses on innovative research that enhances treatment outcomes for individuals with renal conditions. Through collaborative partnerships with healthcare professionals and research institutions, Praxisverbund Dialyse und Apherese aims to facilitate rigorous clinical trials that adhere to the highest ethical and scientific standards. Their dedication to evidence-based practices and patient-centered research positions them as a trusted entity in the clinical research landscape.

Locations

Patients applied

0 patients applied

Trial Officials

Roland E Winkler, PhD

Study Director

Praxisverbund fuer Dialyse und Apherese Rostock

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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