The EASi-KIDNEY trial has commenced to determine if vicadrostat (BI 690517) can improve clinical outcomes for individuals with chronic kidney disease (CKD) when used alongside current standard treatments. This international study aims to enroll approximately 11,000 participants across 15 to 20 countries and is being sponsored by Boehringer Ingelheim. The first participants have been recruited in Oxford.
Chronic kidney disease affects an estimated 850 million people worldwide and is a major contributor to cardiovascular disease and premature death. Despite available treatments like empagliflozin, many CKD patients continue to experience disease progression and increased cardiovascular risk, creating an urgent need for additional therapeutic options.
Trial Design and Objectives
The EASi-KIDNEY trial is designed to evaluate the efficacy of vicadrostat in combination with empagliflozin compared to empagliflozin alone. Participants will be randomly assigned to receive either vicadrostat plus empagliflozin or empagliflozin plus a placebo. The primary outcome measures include the risk of kidney disease progression, hospitalization for heart failure, and death from cardiovascular disease.
Professor William Herrington, chief investigator for EASi-KIDNEY, stated, '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 Potential New Treatment
Vicadrostat is a novel selective aldosterone synthase inhibitor developed by Boehringer Ingelheim. A previous Phase II trial demonstrated that vicadrostat, when combined with empagliflozin, led to a significant reduction in albuminuria, a marker of potential kidney benefit, by up to 40%. These promising results have paved the way for the large-scale EASi-KIDNEY Phase III trial.
Dr. Ioannis Sapountzis, Head of Global Therapeutic Areas at Boehringer Ingelheim, commented, '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%.'
Innovative Trial Management Platform
The EASi-KIDNEY trial will be the first to utilize Cantata, a new clinical trial management platform developed by Protas. This platform aims to streamline trial operations, reduce costs, and enhance the experience for both patients and clinicians.
Professor Sir Martin Landray, Chief Executive Officer of Protas, said, 'The EASi-KIDNEY trial will be the first to use this unique clinical trial management technology...to support people living with chronic kidney disease.'
Patient Participation and Timeline
Eligible adults with CKD will be contacted by their healthcare providers to participate in the trial. Participants will be asked to remain in the study for three to four years, with full results expected in 2028/2029. The trial's findings are anticipated to provide valuable insights into the potential of vicadrostat as a new treatment option for chronic kidney disease.
