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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00291603




Registration number
NCT00291603
Ethics application status
Date submitted
13/02/2006
Date registered
14/02/2006
Date last updated
25/04/2007

Titles & IDs
Public title
Short Term Effects of FX Dialysers on QOL and Inflammation
Scientific title
Short-Term Effects of the FX-Class of Haemodialyser on Quality of Life and Inflammatory Markers in Stable Dialysis Patients
Secondary ID [1] 0 0
2005-192
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Failure, Chronic 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - FX-class of dialyser

Treatment: Devices: FX-class of dialyser
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
KD-QOL
Timepoint [1] 0 0
Primary outcome [2] 0 0
Feeling Thermometer
Timepoint [2] 0 0
Secondary outcome [1] 0 0
IL-6
Timepoint [1] 0 0
Secondary outcome [2] 0 0
TNF-alpha
Timepoint [2] 0 0
Secondary outcome [3] 0 0
hs-CRP
Timepoint [3] 0 0
Secondary outcome [4] 0 0
white cell count
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
1. Age >18years

2. Able to provide informed consent

3. On haemodialysis for 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Joondalup Health Campus Satellite Dialysis Unit - Perth
Recruitment postcode(s) [1] 0 0
6050 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Sir Charles Gairdner Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00291603
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neil C Boudville, MD
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00291603