A new multinational clinical trial 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 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, UK.

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.

The EASi-KIDNEY 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.

40% improvement with vicadrostat

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%.”

Diana Spencer, Senior Digital Content Editor, DDW