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

Renal Dialysis Clinical Trial

— HiCOF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824837
• Other study ID #: 02975
• Secondary ID: AHHREC02975
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 16, 2009
• Last updated: July 6, 2009
• Start date: October 2008
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: Austin Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Dialysis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Austin Health	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Austin Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta2-microglobulin removal by new larger pore membrane versus standard haemodialysis membrane		5 weeks (2 weeks in each arm, 1-week washout period)	No
Secondary	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)	Yes
Secondary	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)	No