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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00824837




Registration number
NCT00824837
Ethics application status
Date submitted
16/01/2009
Date registered
16/01/2009
Date last updated
6/07/2009

Titles & IDs
Public title
Study of beta2-Microglobulin Removal by Standard Versus New High Cut-Off Haemodialysis Membrane
Scientific title
Randomised, Cross Over Pilot Study Comparing Removal of beta2-Microglobulin by Standard Haemodialysis to Haemodialysis With a Novel Dialysis Membrane (P2SH) in Chronic Dialysis Patients
Secondary ID [1] 0 0
AHHREC02975
Secondary ID [2] 0 0
02975
Universal Trial Number (UTN)
Trial acronym
HiCOF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Dialysis 0 0
Renal Dialysis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Larger pore haemodialysis membrane
Other interventions - Standard haemodialysis membrane
Other interventions - Larger pore haemodialysis membrane
Other interventions - Standard haemodialysis membrane

Experimental: A - New larger pore membrane

Active Comparator: B - Standard haemodialysis membrane

Experimental: A - New larger pore membrane

Active Comparator: B - Standard haemodialysis membrane


Other interventions: Larger pore haemodialysis membrane
Patients receive haemodialysis sessions 3 times a week. They are randomized to start with either treatment A (experimental arm) or treatment B (active comparator arm) and continue for 2 weeks, followed by a 1-week washout period. The patients then cross-over and receive the other treatment (either B or A) for 2 weeks.

Other interventions: Standard haemodialysis membrane
Patients receive haemodialysis sessions 3 times a week. They are randomized to start with either treatment A (experimental arm) or treatment B (active comparator arm) and continue for 2 weeks, followed by a 1-week washout period. The patients then cross-over and receive the other treatment (either B or A) for 2 weeks.

Other interventions: Larger pore haemodialysis membrane
Patients receive haemodialysis sessions 3 times a week. They are randomized to start with either treatment A (experimental arm) or treatment B (active comparator arm) and continue for 2 weeks, followed by a 1-week washout period. The patients then cross-over and receive the other treatment (either B or A) for 2 weeks.

Other interventions: Standard haemodialysis membrane
Patients receive haemodialysis sessions 3 times a week. They are randomized to start with either treatment A (experimental arm) or treatment B (active comparator arm) and continue for 2 weeks, followed by a 1-week washout period. The patients then cross-over and receive the other treatment (either B or A) for 2 weeks.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Beta2-microglobulin removal by new larger pore membrane versus standard haemodialysis membrane
Timepoint [1] 0 0
5 weeks (2 weeks in each arm, 1-week washout period)
Primary outcome [2] 0 0
Beta2-microglobulin removal by new larger pore membrane versus standard haemodialysis membrane
Timepoint [2] 0 0
5 weeks (2 weeks in each arm, 1-week washout period)
Secondary outcome [1] 0 0
Albumin loss with the use of new larger pore membrane compared with standard haemodialysis membrane
Timepoint [1] 0 0
5 weeks (2 weeks in each arm, 1-week washout period)
Secondary outcome [2] 0 0
Removal of low-molecular-weight solutes by new larger pore membrane versus standard haemodialysis membrane
Timepoint [2] 0 0
5 weeks (2 weeks in each arm; 1-week washout period)
Secondary outcome [3] 0 0
Albumin loss with the use of new larger pore membrane compared with standard haemodialysis membrane
Timepoint [3] 0 0
5 weeks (2 weeks in each arm, 1-week washout period)
Secondary outcome [4] 0 0
Removal of low-molecular-weight solutes by new larger pore membrane versus standard haemodialysis membrane
Timepoint [4] 0 0
5 weeks (2 weeks in each arm; 1-week washout period)

Eligibility
Key inclusion criteria
- Chronic haemodialysis patients for more than 2 years

- Urine output <100 mL per day

- 3 haemodialysis sessions per week

- Permanent arteriovenous dialysis access
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Serum albumin <25 g/L

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1/Phase 2
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
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)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether a novel haemodialysis membrane, compared
with the standard dialysis membrane, will increase the removal of beta2-microglobulin in
chronic dialysis patients.
Trial website
https://clinicaltrials.gov/show/NCT00824837
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rinaldo Bellomo, MBBS,MD,FRACP
Address 0 0
Director Intensive Care Research, Austin Health
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
Other publications