Study of beta2-Microglobulin Removal by Standard Versus New High Cut-Off Haemodialysis Membrane

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Renal Dialysis

Intervention / Treatment
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* Other: Larger pore haemodialysis membrane
* Other: Standard haemodialysis membrane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>New larger pore membrane | Other: Larger pore haemodialysis membrane<br>* 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.<br>* Other names: Gambro;Other: Standard haemodialysis membrane<br>* 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.<br>|
| Active Comparator: B<br>Standard haemodialysis membrane | Other: Larger pore haemodialysis membrane<br>* 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.<br>* Other names: Gambro;Other: Standard haemodialysis membrane<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 5 weeks (2 weeks in each arm; 1-week washout period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beta 2 microglobulin, haemodialysis, albumin