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Short Term Effects of FX Dialysers on QOL and Inflammation

This study has been completed.
Sponsor:
Information provided by:
Sir Charles Gairdner Hospital
ClinicalTrials.gov Identifier:
NCT00291603
First received: February 13, 2006
Last updated: April 24, 2007
Last verified: April 2007
History of Changes
  Purpose

Background:

The new hollow fibre FX-class of dialysers (Fresenius Medical Care, Bad Homburg, Germany) features a number of technological improvements that may benefit the patient. This includes the use of the advanced high-flux polysulfone membrane, Helixone®, which has an extremely high endotoxin retaining capability. Theoretically leading to reduced systemic inflammation in the patient, which is an important factor for morbidity and mortality with dialysis.

The dialysis membrane is the first to be manufactured using membrane-spinning procedures (nano-controlled spinning technology) that enables the membrane to be modulated at the nano-scale level. The resultant membrane is able to extremely efficiently remove middle molecules, along with minimal loss of albumin.

These features may lead to improved patient outcomes, including reduced systemic inflammation and improved quality of life.

Aims:

  1. To assess the short-term effects of the FX-class Dialyser on quality of life in stable haemodialysis patients
  2. To assess the short-term effects of the FX-class Dialyser on inflammatory markers in stable haemodialysis patients.

Condition Intervention Phase
Kidney Failure, Chronic
 Device: FX-class of dialyser
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short-Term Effects of the FX-Class of Haemodialyser on Quality of Life and Inflammatory Markers in Stable Dialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sir Charles Gairdner Hospital:

Primary Outcome Measures:
  • KD-QOL
  • Feeling Thermometer

Secondary Outcome Measures:
  • IL-6
  • TNF-alpha
  • hs-CRP
  • white cell count

Estimated Enrollment: 50
Study Start Date: February 2006
Study Completion Date: December 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18years
  2. Able to provide informed consent
  3. On haemodialysis for 3 months

Exclusion Criteria:

  1. Active inflammatory, infective or neoplastic process within the last 1 month
  2. Active major psychiatric condition
  3. Currently on haemodiafiltration as haemodialysis modality
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291603

Locations
Australia, Western Australia
Joondalup Health Campus Satellite Dialysis Unit
Perth, Western Australia, Australia, 6050
Sponsors and Collaborators
Sir Charles Gairdner Hospital
Investigators
Principal Investigator: Neil C Boudville, MD The University of Western Australia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00291603     History of Changes
Other Study ID Numbers: 2005-192
Study First Received: February 13, 2006
Last Updated: April 24, 2007
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Sir Charles Gairdner Hospital:
dialysis
Renal Dialysis
inflammation
quality of life
End Stage Kidney Failure

Additional relevant MeSH terms:
Inflammation
Kidney Failure, Chronic
Renal Insufficiency
Pathologic Processes
 Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013