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

Austin Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Renal Dialysis

Treatments: Other: Larger pore haemodialysis membrane; Other: Standard haemodialysis membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT00824837

AHHREC02975

02975

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups

A

Experimental group

Description:

New larger pore membrane

Treatment:

Other: Larger pore haemodialysis membrane

Other: Standard haemodialysis membrane

B

Active Comparator group

Description:

Standard haemodialysis membrane

Treatment:

Other: Larger pore haemodialysis membrane

Other: Standard haemodialysis membrane