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

Sponsor:	Austin Health
Information provided by:	Austin Health
ClinicalTrials.gov Identifier:	NCT00824837

Purpose

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.

Condition	Intervention	Phase
Renal Dialysis	Other: Larger pore haemodialysis membrane Other: Standard haemodialysis membrane	Phase I Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis

U.S. FDA Resources

Further study details as provided by Austin Health:

Primary Outcome Measures:

Beta2-microglobulin removal by new larger pore membrane versus standard haemodialysis membrane [ Time Frame: 5 weeks (2 weeks in each arm, 1-week washout period) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Albumin loss with the use of new larger pore membrane compared with standard haemodialysis membrane [ Time Frame: 5 weeks (2 weeks in each arm, 1-week washout period) ] [ Designated as safety issue: Yes ]
Removal of low-molecular-weight solutes by new larger pore membrane versus standard haemodialysis membrane [ Time Frame: 5 weeks (2 weeks in each arm; 1-week washout period) ] [ Designated as safety issue: No ]

Enrollment:	8
Study Start Date:	October 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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.

Arms

Assigned Interventions

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 Name: 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 Name: 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824837

Locations

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

Sponsors and Collaborators

Austin Health

Investigators

Principal Investigator:

Rinaldo Bellomo, MBBS,MD,FRACP

Director Intensive Care Research, Austin Health

More Information

No publications provided

Responsible Party:	Rinaldo Bellomo, Austin Health
ClinicalTrials.gov Identifier:	NCT00824837 History of Changes
Other Study ID Numbers:	02975, AHHREC02975
Study First Received:	January 16, 2009
Last Updated:	July 6, 2009
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Austin Health:

beta 2 microglobulin
haemodialysis
albumin

ClinicalTrials.gov processed this record on February 09, 2012