Renal DialysisPhase 1/2HiCOFNCT00824837
Study of beta2-Microglobulin Removal by Standard Versus New High Cut-Off Haemodialysis Membrane
A Phase 1/2 study testing Larger pore haemodialysis membrane and Standard haemodialysis membrane in people with Renal Dialysis, run by Austin Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- Larger pore haemodialysis membrane and Standard haemodialysis membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2008to Dec 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic haemodialysis patients for more than 2 years
- Urine output <100 mL per day
- 3 haemodialysis sessions per week
- Permanent arteriovenous dialysis access
Who cannot join
- Serum albumin <25 g/L
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
Despite advances in treatment of kidney diseases, morbidity and mortality of chronic dialysis patients remains unsatisfactory. Standard haemodialysis membranes remove middle-sized molecule solutes poorly such as beta2-microglobulin, which has a pathogenic role in dialysis-related amyloidosis. Pre-dialysis beta2-microglobulin concentration has been shown to be independently predictive of mortality. A new polyamide haemodialysis membrane has been developed with increased pore size to increase the removal of middle-sized uraemic toxins such as beta2-microglobulin. This study aims to evaluate the effectiveness of the new membrane in beta2-microglobulin removal compared with standard haemodialysis membrane in dialysis patients and the degree of increased loss of albumin as a potential limiting factor of its use.
- Conditions
- Renal Dialysis
- Being tested
- Larger pore haemodialysis membrane, Standard haemodialysis membrane
- Keywords
- beta 2 microglobulin, haemodialysis, albumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Larger pore haemodialysis membraneOther
Also called Gambro
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.
Standard haemodialysis membraneOther
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | New larger pore membrane Receives: Other: Larger pore haemodialysis membrane; Other: Standard haemodialysis membrane |
| B | Active comparator | Standard haemodialysis membrane Receives: Other: Larger pore haemodialysis membrane; Other: Standard haemodialysis membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta2-microglobulin removal by new larger pore membrane versus standard haemodialysis membrane
Measured: 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
Measured: 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
Measured: 5 weeks (2 weeks in each arm; 1-week washout period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Investigators
- Rinaldo Bellomo, MBBS,MD,FRACP, Principal investigator, Director Intensive Care Research, Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824837
- Sponsor's protocol ID
- 02975
- Other IDs
- AHHREC02975
- Acronym
- HiCOF
- Status last verified
- Jan 2009
- First submitted
- 16 Jan 2009
- Last updated
- 7 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00824837
- Acronym / sponsor ID
- HiCOF / 02975
- Conditions
- Renal Dialysis
- Keywords
- beta 2 microglobulin, haemodialysis, albumin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Austin HealthOther government
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite advances in treatment of kidney diseases, morbidity and mortality of chronic dialysis patients remains unsatisfactory. Standard haemodialysis membranes remove middle-sized molecule solutes poorly such as beta2-microglobulin, which has a pathogenic role in dialysis-related amyloidosis. Pre-dialysis beta2-microglobulin concentration has been shown to be independently predictive of mortality. A new polyamide haemodialysis membrane has been developed with increased pore size to increase the removal of middle-sized uraemic toxins such as beta2-microglobulin. This study aims to evaluate the effectiveness of the new membrane in beta2-microglobulin removal compared with standard haemodialysis membrane in dialysis patients and the degree of increased loss of albumin as a potential limiting factor of its use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Larger pore haemodialysis membrane, Other: Standard haemodialysis membraneNew larger pore membrane |
| B | Active comparator | Other: Larger pore haemodialysis membrane, Other: Standard haemodialysis membraneStandard haemodialysis membrane |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic haemodialysis patients for more than 2 years
- Urine output <100 mL per day
- 3 haemodialysis sessions per week
- Permanent arteriovenous dialysis access
Key exclusion criteria (1 listed)
- Serum albumin <25 g/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Larger pore haemodialysis membraneAlso: GambroPatients 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 | A, B |
| Standard haemodialysis membranePatients 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 | A, B |
Primary outcome
Beta2-microglobulin removal by new larger pore membrane versus standard haemodialysis membrane
Time frame: 5 weeks (2 weeks in each arm, 1-week washout period)
2 secondary outcomes
Albumin loss with the use of new larger pore membrane compared with standard haemodialysis membrane
Time frame: 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
Time frame: 5 weeks (2 weeks in each arm; 1-week washout period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rinaldo Bellomo, MBBS,MD,FRACP principal investigator
Director Intensive Care Research, Austin Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Larger pore haemodialysis membrane and Standard haemodialysis membrane in people with Renal Dialysis, run by Austin Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta2-microglobulin removal by new larger pore membrane versus standard haemodialysis membrane (time frame: 5 weeks (2 weeks in each arm, 1-week washout period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2009.