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Trial registered on ANZCTR


Registration number
ACTRN12610000427077
Ethics application status
Approved
Date submitted
20/05/2010
Date registered
26/05/2010
Date last updated
26/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of conventional high-flux versus a novel Helixone dialysis membrane on oxidative stress in stable haemodialysis patients.
Scientific title
The impact of standard high flux polysulfone versus novel high flux polysulfone (Helixone) dialysis membranes on inflammatory markers in stable haemodialysis patients: A randomised single blinded controlled clinical trial.
Secondary ID [1] 1039 0
CRG080600085.
Cochrane Renal Group
Universal Trial Number (UTN)
Trial acronym
Oxidative stress and dialysis membranes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemodialysis 243755 0
Condition category
Condition code
Renal and Urogenital 257539 257539 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of conventional high-flux dialysis (HF80 polysulfone membrane) with helixone high-flux dialysis (FX series polysulfone membrane). The FX series membrane has a higher molecular flux enabling greater clearance of middle molecules compared to the standard high flux membranes. All participants will maintain their standard dialysis regime (duration of dialysis per session, sessions per week and blood flow speed). The only difference between groups is the dialysis membrane used for the 12 month period
Intervention code [1] 256501 0
Treatment: Devices
Comparator / control treatment
conventional high-flux versus helixone high-flux dialysis.
The FX series membrane has a higher molecular flux enabling greater clearance of middle molecules compared to the standard high flux membranes. All participants will maintain their standard dialysis regime (duration of dialysis session, sessions per week and blood flow speed). The only difference between groups is the dialysis membrane used for the 12 month period
Control group
Active

Outcomes
Primary outcome [1] 240823 0
The effects of the dialyser membrane on markers of plasma protein and lipid oxidation, inflammatory markers including pro-inflammatory cytokines and cell adhesion molecules over a 12 month period. The primay outcome is a composite of the measures of oxidative stress listed below
Protein thiols are measured colorimetrically. Protein-bound dityrosine fluorescence and protein-bound lipofuscin-like fluorophores are measured fluorometrically. Protein carbonyls are measured colorimetrically. Plasma oxidised low density lipoproteins are measured by immunoassay. Protein peroixdes are measured enzymatically. Plasma C reactive protein is measured by high sensitivity immunoturbidimetric assay. Interleukin-6 (IL-6) and vascular cell adhesion molecule (VCAM) are measured by enzyme linked immunosorbent assays.
Timepoint [1] 240823 0
Baseline, 3 months and 12 months
Secondary outcome [1] 264243 0
Nil
Timepoint [1] 264243 0
Nil

Eligibility
Key inclusion criteria
stable haemodialysis patients aged from 18 to 75 years; using established arterio-venous fistulae or fistulae constructed from synthetic grafts; and who had been established on haemodialysis for at least 3 months.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
an inability to give informed consent; unlikely to remain on dialysis for at least 9 months (either due to impending demise or transplantation); prior demonstrated allergy to polysulfone membranes; dialysis via a central venous access catheter; any evidence of an ongoing inflammatory response including infection, auto-immune disorders, vasculitis, treatment with any immunosuppressive agents or the presence of any malignancy.

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)
Patients were recruited from 2 low dependency satellite dialysis units by nephrology staff. Following a 1 month run in low flux polysulfone dialysis membranes they were randomly allocated to either conventional high-flux dialysis membranes (HF80) or helixone high flux dialysis membranes (HF series).
Allocation was by a third party off site and independent of the investigators
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was performed by a third party matching an alphabetical list of eligible screening participantts to a computer generated random number list in a single block. (Prism 4 for windows).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256988 0
Commercial sector/Industry
Name [1] 256988 0
Fresenius Medical Care Southeast Asia
Address [1] 256988 0
Fresenius Medical Care
61 Lavender Street
Milsons Point
NSW 2061
Country [1] 256988 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Fresenius Medical Care Southeast Asia
Address
Fresenius Medical Care
61 Lavender Street
Milsons Point
NSW 2061
Country
Australia
Secondary sponsor category [1] 256252 0
None
Name [1] 256252 0
Address [1] 256252 0
Country [1] 256252 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258998 0
Monash Medical Centre Human Research and Ethics Committee
Ethics committee address [1] 258998 0
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 258998 0
Australia
Date submitted for ethics approval [1] 258998 0
Approval date [1] 258998 0
01/12/2003
Ethics approval number [1] 258998 0

Summary
Brief summary
The hypothesis to be tested by this study is that the improved clearance of middle molecules (thought to be important uremic toxins) by the new FX 80 membrane would lead to less oxidative stress and inflammation when compared to dialysis using a standard hig-flux membrane.
Trial website
Trial related presentations / publications
1. Kerr PG. Sutherland WH. de Jong S. Vaithalingham I. Williams SM. Walker RJ. The impact of standard high-flux polysulfone versus novel high-flux polysulfone dialysis membranes on inflammatory markers: a randomized, single-blinded, controlled clinical trial. American Journal of Kidney Diseases. 49(4):533-9, 2007 Apr.
2. The impact of standard high flux polysulfone versus novel high flux polysulfone (Helixone?) dialysis membranes on inflammatory markers: A randomised single blinded controlled clinical trial. Kerr PG, Sutherland WHF, de Jong S, Vaithalingham I, Williams SM, Walker RJ. Nephrology 2006;11:A32


[added by Gail Higgins 20/08/2007]
Public notes

Contacts
Principal investigator
Name 30208 0
Address 30208 0
Country 30208 0
Phone 30208 0
Fax 30208 0
Email 30208 0
Contact person for public queries
Name 13455 0
Prof, Robert, Walker
Address 13455 0
Head of Department (HOD), Medical & Surgical Sciences, Dunedin School of Medicine, PO Box 913 Dunedin 9054 New Zealand
Country 13455 0
New Zealand
Phone 13455 0
+64 3 4740999
Fax 13455 0
Email 13455 0
rob.walker@stonebow.otago.ac.nz
Contact person for scientific queries
Name 4383 0
Prof, Robert, Walker
Address 4383 0
HOD, Medical & Surgical Sciences, Dunedin School of Medicine, PO Box 913 Dunedin 9054 NZ
Country 4383 0
New Zealand
Phone 4383 0
+64 3 4740999
Fax 4383 0
Email 4383 0
rob.walker@stonebow.otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary