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

Phase 1

Completed

• Conditions: Renal Dialysis
• Interventions: Other: Larger pore haemodialysis membrane; Other: Standard haemodialysis membrane

• Registration Number: NCT00824837
• Lead Sponsor: Austin Health

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 Timeline

• Study Start: 2008-10
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-01
• Study First Submitted: 2009-01-16
• Study First Submitted QC: 2009-01-16
• Study First Posted: 2009-01-19
• Last Update Submitted: 2009-07-06
• Last Update Posted: 2009-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Larger pore haemodialysis membrane	New larger pore membrane
A	Standard haemodialysis membrane	New larger pore membrane
B	Larger pore haemodialysis membrane	Standard haemodialysis membrane
B	Standard haemodialysis membrane	Standard haemodialysis membrane

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Austin Health; 🇦🇺 Melbourne, Victoria, Australia