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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00824837
Ethics application status
Date submitted
16/01/2009
Date registered
19/01/2009
Date last updated
7/07/2009

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
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

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.
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)
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)

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
Sex
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
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
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
8
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
Government body
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00824837