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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


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
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