Short Term Effects of FX Dialysers on QOL and Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00291603
Recruitment Status : Completed
First Posted : February 14, 2006
Last Update Posted : April 25, 2007
Information provided by:
Sir Charles Gairdner Hospital

Brief Summary:


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.


  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 or disease Intervention/treatment Phase
Kidney Failure, Chronic Device: FX-class of dialyser Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : February 2006
Actual Study Completion Date : December 2006

Primary Outcome Measures :
  1. KD-QOL
  2. Feeling Thermometer

Secondary Outcome Measures :
  1. IL-6
  2. TNF-alpha
  3. hs-CRP
  4. white cell count

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00291603

Australia, Western Australia
Joondalup Health Campus Satellite Dialysis Unit
Perth, Western Australia, Australia, 6050
Sponsors and Collaborators
Sir Charles Gairdner Hospital
Principal Investigator: Neil C Boudville, MD The University of Western Australia Identifier: NCT00291603     History of Changes
Other Study ID Numbers: 2005-192
First Posted: February 14, 2006    Key Record Dates
Last Update Posted: April 25, 2007
Last Verified: April 2007

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

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