This is a dose-finding and cardiovascular outcomes study of the study treatment in adults with end-stage kidney disease (ESKD) undergoing dialysis
This study is testing a new drug to see if it can help lower the risk of heart attacks and strokes in people with end-stage kidney disease who are on dialysis. The drug will be compared to a placebo, will run for 3 to 5 years and includes regular health checks and tests.
Anticipated date enrolment will close: December 2027
Who can take part
People may be able to take part if they:
- are aged 18 or over
- are receiving dialysis for kidney failure
- have either diabetes or heart disease
- are not currently pregnant
- are not taking part in another study
- can attend regular study visits
What is involved for participants
- Study drug (or placebo) given through a drip every 4 weeks with up to 69 study visits over 3 to 5 years
- Regular health checks including weight, blood pressure, and heart rate
- Blood tests every few weeks
- Questionnaires using an app
- Regular follow-up after treatment ends
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.