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| ID | Type | Description | Link |
|---|---|---|---|
| AHHREC02975 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | New larger pore membrane |
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| B | Active Comparator | Standard haemodialysis membrane |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Larger pore haemodialysis membrane | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Beta2-microglobulin removal by new larger pore membrane versus standard haemodialysis membrane | 5 weeks (2 weeks in each arm, 1-week washout period) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rinaldo Bellomo, MBBS,MD,FRACP | Director Intensive Care Research, Austin Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin Health | Melbourne | Victoria | 3084 | Australia |
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| Standard haemodialysis membrane | Other | 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. |
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| 5 weeks (2 weeks in each arm; 1-week washout period) |