A new trial could transform the treatment of chronic kidney disease (CKD) and could benefit millions of people globally.
Researchers from The George Institute for Global Health have been awarded $5.5 million by the National Health and Research Medical Council for the largest ever project grant awarded for research into kidney disease, with additional support provided by Bayer. This important collaboration will bring together researchers from around the world in a new initiative aiming to prevent cardiovascular disease (heart attacks, strokes, heart failure and death) in people who have advanced kidney disease.
Globally, more than 30.5 million people have advanced stages of CKD, and another three million people are receiving dialysis for ESKD. In 2013, CKD was associated with 4% of all deaths or 2.2 million deaths worldwide, of which more than half (1.2 million) were attributed to cardiovascular causes.
Despite the exceptionally high mortality rates, there are few treatments proven to benefit people with CKD. Some treatments that work in the general population don't perform as well in the presence of kidney disease, while others have a higher risk of side effects. People with CKD have also largely been excluded from CVD trials, leaving a huge gap in both evidence and treatment.
This new international trial, being led by The George Institute and supported by Kidney Health Australia, Bayer and leading researchers from around the world, will evaluate whether a low dose of a blood-thinning medication, that is beneficial in people with cardiovascular disease, will also safely reduce the number of heart attacks, strokes and deaths with people with CKD.
Lead researcher Sunil Badve, Senior Research Fellow and Associate Professor of Medicine at The George Institute for Global Health, UNSW Sydney, said: "Patients with chronic kidney disease are missing out on lifesaving treatments. We hope this trial will help millions of people around the world by providing them with a medication that will prevent them from dying of a heart attack or suffering a stroke."
"It's an exciting opportunity to address this unmet need and hopefully deliver a treatment that will save lives and also save money as CKD is a very complex condition to manage," added Associate Professor Badve, who is also a nephrologist at St George Hospital, Sydney.
Around 2000 patients with CKD in Australia, New Zealand, Malaysia, India, China, Canada and the UK will take part in the five-year randomised trial and receive the blood thinning medication at a low dose to try to avoid associated side effects.
Dr Eduardo Pimenta, Head of Medical Affairs, Bayer ANZ, said: "Bayer is proud to partner with the George Institute and Kidney Health Australia to address a significant gap in the evidence and management of CVD in people with end-stage kidney disease. Collaborations such as this underscore our commitment to facilitating ground breaking research to improve patient outcomes in the future."
Dr Shilpa Jesudason, Clinical Director of Kidney Health Australia, which is working with The George Institute in regards to patient involvement, said: "As the peak organisation for patients living with kidney disease, their families and community, Kidney Health Australia is excited to be partnering with The George Institute to bring the consumer voice to this study. Patient and consumer engagement at all stages of research design, trial implementation and knowledge dissemination adds enormous value to the quality, conduct and relevance of clinical trials.
"Given the massive burden of cardiovascular disease in people with end-stage kidney disease, it is important that patients partner with researchers for the benefit of all."
When completed it will be the first and the largest ever trial evaluation blood-thinning medications for people with CKD.