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Short Term Effects of FX Dialysers on QOL and Inflammation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00291603
First Posted: February 14, 2006
Last Update Posted: April 25, 2007
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.
Information provided by:
Sir Charles Gairdner Hospital
  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
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

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

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
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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00291603     History of Changes
Other Study ID Numbers: 2005-192
First Submitted: February 13, 2006
First Posted: February 14, 2006
Last Update Posted: April 25, 2007
Last Verified: April 2007

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

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