Study of beta2-Microglobulin Removal by Standard Versus New High Cut-Off Haemodialysis Membrane
HiCOF
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
2 other identifiers
interventional
8
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 16, 2009
CompletedFirst Posted
Study publicly available on registry
January 19, 2009
CompletedJuly 7, 2009
January 1, 2009
2 months
January 16, 2009
July 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Beta2-microglobulin removal by new larger pore membrane versus standard haemodialysis membrane
5 weeks (2 weeks in each arm, 1-week washout period)
Secondary Outcomes (2)
Albumin loss with the use of new larger pore membrane compared with standard haemodialysis membrane
5 weeks (2 weeks in each arm, 1-week washout period)
Removal of low-molecular-weight solutes by new larger pore membrane versus standard haemodialysis membrane
5 weeks (2 weeks in each arm; 1-week washout period)
Study Arms (2)
A
EXPERIMENTALNew larger pore membrane
B
ACTIVE COMPARATORStandard haemodialysis membrane
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Chronic haemodialysis patients for more than 2 years
- Urine output \<100 mL per day
- haemodialysis sessions per week
- Permanent arteriovenous dialysis access
You may not qualify if:
- Serum albumin \<25 g/L
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Austin Healthlead
Study Sites (1)
Austin Health
Melbourne, Victoria, 3084, Australia
Study Officials
- PRINCIPAL INVESTIGATOR
Rinaldo Bellomo, MBBS,MD,FRACP
Director Intensive Care Research, Austin Health
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
January 16, 2009
First Posted
January 19, 2009
Study Start
October 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
July 7, 2009
Record last verified: 2009-01