Renal Dialysis
Conditions
Keywords
beta 2 microglobulin, haemodialysis, albumin
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.
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.
Interventions
OTHERLarger 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.
OTHERStandard 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.
Sponsors
Austin Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Exclusion criteria
* Serum albumin \<25 g/L
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | 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 | 5 weeks (2 weeks in each arm; 1-week washout period) |
Countries
Australia
Outcome results
None listed