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Completed

NCT Number: NCT00824837

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

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.

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Key information

Conditions

Renal Dialysis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Austin Health

Melbourne, Victoria, 3084, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Larger pore haemodialysis membrane

Other

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

Standard haemodialysis membrane

Other

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Austin Health

Other Gov

Registry information

Official study 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

Acronym: HiCOF

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 19, 2009
Registry last updated
Jul 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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