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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Dialysis
• Intervention / Treatment: Other: Larger pore haemodialysis membrane; Other: Standard haemodialysis membrane

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3084
      • Austin Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; New larger pore membrane	Other: Larger 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.; Other Names: Gambro; Other: Standard 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.
Active Comparator: B; Standard haemodialysis membrane	Other: Larger 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.; Other Names: Gambro; Other: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Austin Health
• Investigators: Principal Investigator: Rinaldo Bellomo, MBBS,MD,FRACP, Director Intensive Care Research, Austin Health

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: January 16, 2009
• First Submitted That Met QC Criteria: January 16, 2009
• First Posted (Estimate): January 19, 2009

Study Record Updates

• Last Update Posted (Estimate): July 7, 2009
• Last Update Submitted That Met QC Criteria: July 6, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: albumin; haemodialysis; beta 2 microglobulin
• Other Study ID Numbers: 02975; AHHREC02975