Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000132549
Ethics application status
Approved
Date submitted
5/04/2006
Date registered
11/04/2006
Date last updated
17/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised crossover trial of a porous haemodialysis membrane compared to a conventional high-flux membrane in stable haemodialysis patients to determine the short term impact on inflammatory and nutritional indices.
Scientific title
Randomised crossover trial of a porous haemodialysis membrane compared to a conventional high-flux membrane in stable haemodialysis patients to determine the short term impact on inflammatory and nutritional indices.
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemodialysis 1099 0
End Stage Renal Failure 1100 0
Condition category
Condition code
Renal and Urogenital 1179 1179 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
30 stable haemodialysis patients will be randomly assigned to either continue on conventional high-flux dialysis with the FX60 membrane or the new modified-FX membrane. Equal numbers in each group. Cross-over after 6 weeks. Total study duration 12 weeks.
Intervention code [1] 960 0
Treatment: Devices
Comparator / control treatment
Conventional high-flux dialysis with the FX60 membrane
Control group
Active

Outcomes
Primary outcome [1] 1590 0
Nutritional indices
Timepoint [1] 1590 0
Assessed in the serum at baseline, 2,6, 8 and 12 weeks
Primary outcome [2] 1591 0
Inflammatory indices
Timepoint [2] 1591 0
Assessed in the serum at baseline, 2,6, 8 and 12 weeks
Primary outcome [3] 1592 0
Dialysate albumin
Timepoint [3] 1592 0
Assessed in the serum at baseline, 2,6, 8 and 12 weeks
Secondary outcome [1] 2883 0
Serum albumin, URR (urea reduction ratio).
Timepoint [1] 2883 0
Assessed at baseline and at 6 and 12 weeks.

Eligibility
Key inclusion criteria
Stable haemodialysis patients, currently dialysed with FX60 dialysers.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
central randomisation by third party using random number chart generated by computer package
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generation by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1290 0
Commercial sector/Industry
Name [1] 1290 0
Fresenius Asia-Pacific
Country [1] 1290 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
Fresenius
Address
Country
Germany
Secondary sponsor category [1] 1140 0
None
Name [1] 1140 0
nil
Address [1] 1140 0
Country [1] 1140 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This trial examines whether a new dialysis membrane has potential advantages to the patients by way of determining whether the membrane results in less of an inflammatory state - reflected by both markers of inflammation and nutrition in the blood. It is a short term pilot study only, as a possible lead in to a longer more detailed study. The dialysis membranes will be supplied blinded in that all will look the same (but carry a code) such that the treating dialysis nurses and the patients will be unaware of which dialyser is in use at any given time.
Trial website
Trial related presentations / publications
Accepted in Am J Kidney Dis - yet to be published
Public notes

Contacts
Principal investigator
Name 35605 0
Address 35605 0
Country 35605 0
Phone 35605 0
Fax 35605 0
Email 35605 0
Contact person for public queries
Name 10149 0
Peter Kerr
Address 10149 0
Nephrology
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 10149 0
Australia
Phone 10149 0
+61 3 95943520
Fax 10149 0
+61 3 95946530
Email 10149 0
[email protected]
Contact person for scientific queries
Name 1077 0
Peter Kerr
Address 1077 0
Nephrology
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 1077 0
Australia
Phone 1077 0
+61 3 95943520
Fax 1077 0
+61 3 95946530
Email 1077 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.