NCT00291603

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

April 25, 2007

Status Verified

April 1, 2007

First QC Date

February 13, 2006

Last Update Submit

April 24, 2007

Conditions

Kidney Failure, Chronic

Keywords

dialysisRenal Dialysisinflammationquality of lifeEnd Stage Kidney Failure

Outcome Measures

Primary Outcomes (2)

  • KD-QOL

  • Feeling Thermometer

Secondary Outcomes (4)

  • IL-6

  • TNF-alpha

  • hs-CRP

  • white cell count

Interventions

FX-class of dialyserDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18years
  • Able to provide informed consent
  • On haemodialysis for 3 months

You may not qualify if:

  • Active inflammatory, infective or neoplastic process within the last 1 month
  • Active major psychiatric condition
  • Currently on haemodiafiltration as haemodialysis modality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joondalup Health Campus Satellite Dialysis Unit

Perth, Western Australia, 6050, Australia

Location

MeSH Terms

Conditions

Kidney Failure, ChronicInflammationRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Neil C Boudville, MD

    The University of Western Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2006

First Posted

February 14, 2006

Study Start

February 1, 2006

Study Completion

December 1, 2006

Last Updated

April 25, 2007

Record last verified: 2007-04

Locations

AU(1)