A multinational clinical trial, EASi-KIDNEY, has begun to evaluate the potential of vicadrostat (BI 690517) in slowing the progression of chronic kidney disease (CKD). The trial will assess vicadrostat in combination with existing treatments, such as empagliflozin, in a large patient population.
The EASi-KIDNEY trial plans to enroll approximately 11,000 participants across 15 to 20 countries. The first participants have been recruited in Oxford, UK. CKD affects approximately 1 in 10 adults globally and is a leading cause of death worldwide.
Evaluating Vicadrostat's Potential
The EASi-KIDNEY trial will investigate whether the combination of vicadrostat and empagliflozin reduces the risk of kidney disease progression, hospitalization for heart failure, or death from cardiovascular disease in people with CKD, compared to empagliflozin alone, when added to standard medical care. Participants will be randomized to receive either the combination of vicadrostat and empagliflozin or empagliflozin plus a placebo.
Professor William Herrington, Chief Investigator for EASi-KIDNEYTM at Oxford Population Health, stated, '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.'
Vicadrostat: A Novel Aldosterone Synthase Inhibitor
Vicadrostat, a novel selective aldosterone synthase inhibitor developed by Boehringer Ingelheim, showed promising results in an earlier Phase II trial. According to Dr. Ioannis Sapountzis, Head of Global Therapeutic Areas at Boehringer Ingelheim, the combination of vicadrostat and empagliflozin demonstrated 'a significant reduction of albuminuria, a marker of potential kidney benefit, by up to 40%.'
Streamlining Trial Management with Cantata
The EASi-KIDNEY trial marks the first application of Protas' new clinical trial management platform, Cantata. Professor Sir Martin Landray, Chief Executive Officer of Protas, explained that Cantata was developed 'to transform large-scale clinical trials' by making them 'less complex, more cost-effective,' and providing 'a much better experience for patients and clinicians.'
Trial Outlook
Eligible adults with CKD will be contacted by their healthcare providers to participate in the trial. Participants will remain in the study for three to four years, with full results expected in 2028/2029. The trial aims to address the unmet need for additional treatments to improve outcomes for individuals with CKD.
