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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Austin Health
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Beta2-microglobulin removal by new larger pore membrane versus standard haemodialysis membrane
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
A
New larger pore membrane
Intervention: Larger pore haemodialysis membrane (Other)
A
New larger pore membrane
Intervention: Standard haemodialysis membrane (Other)
B
Standard haemodialysis membrane
Intervention: Larger pore haemodialysis membrane (Other)
B
Standard haemodialysis membrane
Intervention: Standard haemodialysis membrane (Other)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- 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))