The first participants have been recruited in Oxford for a new multinational clinical trial that will investigate whether a novel treatment can help slow the progression of chronic kidney disease (CKD).
The EASi-KIDNEY trial will evaluate whether vicadrostat, also known as BI 690517, improves clinical outcomes in a large group of people living with CKD when it is given in combination with existing treatments.
The trial will run in 15-20 countries around the world, with around 11,000 people expected to participate. The first participants have been recruited in Oxford.
Patrick Wallace, who joined the trial at the Oxford Kidney Unit, part of Oxford University Hospitals NHS Foundation Trust, said 'I wanted to participate in the trial as I am conscious of the vital importance of clinical trials in improving our knowledge of conditions such as chronic kidney disease. It is important to me to contribute towards providing robust evidence for new treatments even if vicadrostat (BI 690517) won't be available to people outside the trial for several years.'
CKD is often a progressive condition that can lead to the need for kidney dialysis or a transplant and increases the risk of cardiovascular disease. It affects about 1 in 10 adults worldwide and is a leading cause of death globally.
The EMPA-KIDNEY trial, led by researchers at Oxford Population Health, demonstrated that empagliflozin reduces the risk of kidney disease progression or death from cardiovascular disease by 28% in patients with CKD with and without diabetes. Empagliflozin is now recommended as a foundational treatment for CKD in many countries. However, there are many people with CKD who, despite the availability of CKD treatments, still experience worsening disease and an increased risk of heart problems.
William Herrington, Professor of Clinical Trials and Epidemiology of Kidney Disease at Oxford Population Health and chief investigator for EASi-KIDNEYTM said 'It is estimated that there are about 850 million people around the world living with chronic kidney disease, which currently has no cure. Additional treatments are urgently required to lessen the often devastating impact of kidney failure on quality of life and reduce the risk of cardiovascular disease and premature death.'
The EASi-KIDNEYTM trial will investigate whether the combination of vicadrostat (BI 690517) and empagliflozin reduces the risk of kidney disease progression, hospitalisation for heart failure, or death from cardiovascular disease in people with CKD compared with empagliflozin, when added on top of standard medical care. Half of the participants will be randomly allocated to receive the combination of vicadrostat and empagliflozin, and half will be randomly allocated to receive empagliflozin plus a matching placebo.
The new compound has been developed by Boehringer Ingelheim who are sponsoring the trial. It has been tested in an earlier (Phase II) trial which showed promising results. 'We are tremendously encouraged by the promising results of our previous trial. By advancing into a global Phase III trial programme, we're taking a crucial step forward in chronic kidney disease care', said Dr Ioannis Sapountzis, Head of Global Therapeutic Areas at Boehringer Ingelheim.
'When given in combination with empagliflozin, our novel selective aldosterone synthase inhibitor, vicadrostat, showed a significant reduction of albuminuria, a marker of potential kidney benefit, by up to 40%. These efforts underline our commitment to transforming the lives of people impacted by this severe disease and other interconnected cardiovascular, renal and metabolic conditions. The potential to ease the burden on healthcare systems and patients is profound. We're proud to be at the forefront of care solutions in this field and are eager to see how EASi-KIDNEY evolves in the coming years.'
Dr Parminder Judge, Senior Clinical Research Fellow at Oxford Population Health, and co-principal investigator, added: 'The results from the new treatment's earlier trial are especially promising. We hope that the effects on urine protein translate into important clinical improvements with long-term treatment in what will be one of the largest trials ever conducted in this population.'
EASi-KIDNEYTM will be the first trial to use the new clinical trial management platform developed by Protas called "Cantata". Protas is a not-for-profit organisation established to facilitate the design and delivery of large-scale, high-quality clinical trials at low cost. Protas's Cantata is a unique, end-to-end trial management system that supports that vision.
Professor Sir Martin Landray, Chief Executive Officer of Protas and Professor of Medicine and Epidemiology at Oxford Population Health said: 'We developed Cantata based on decades of tried-and-tested technology at Oxford in order to transform large-scale clinical trials. Together, our vision has been to design and deliver clinical trials that are less complex, more cost effective, provide a much better experience for patients and clinicians, and have the best chances of providing the answers needed to improve patient care.
'The EASi-KIDNEY trial will be the first to use this unique clinical trial management technology, and we are delighted to have partnered with Oxford Population Health and Boehringer Ingelheim to support people living with chronic kidney disease.'
Adults with CKD who are eligible to participate in the trial will be contacted by their family doctor or hospital consultant. Participants are asked to stay in the study for three-four years and it is hoped that full results will be available in 2028/2029.
