What is the EASi-KIDNEY trial?

EASi-KIDNEY^TM is a clinical trial testing whether the new medication called vicadrostat, also known as BI 690517, taken in combination with a well-tested medication called empagliflozin, can be safely used to lower the risk of worsening kidney disease or heart disease in patients with kidney disease.

In a previous large clinical trial called EMPA-KIDNEY^TM, empagliflozin was shown to safely reduce the need for patients with chronic kidney disease to start dialysis, and it is now widely recommended to treat adults with chronic kidney disease worldwide.

Although empagliflozin substantially improves outcomes in people with kidney disease, it is not a cure and the health risks remain raised for many people. Vicadrostat (BI 690517) is a newly developed medicine that could provide further health benefits to people with kidney disease. Early studies have shown that vicadrostat (BI 690517) might protect the kidneys and heart but this needs to be tested in a large trial.

EASi-KIDNEY^TM aims to recruit about 11000 participants with kidney disease internationally. Half of the participants will take 10mg of vicadrostat (BI 690517) with 10mg of empagliflozin once a day and half will receive a matching inactive pill (placebo) with 10mg of empagliflozin once a day. Participants will be allocated to these two treatment groups randomly (like a toss of a coin) and no participant or researcher will know which patients are receiving vicadrostat (BI 690517) until the end of the trial. This is referred to as a double-blind randomised control trial.

Such large trials are a definitive test of new treatments, and are required by regulators before treatments can be licensed for use. The trial is an enormous undertaking requiring collaboration of clinical staff and patients from as many as 500 hospital clinics from about 15-20 countries. The University of Oxford’s Renal Studies Group is leading the trial and has received a grant from Boehringer Ingelheim, the company who manufactures the drug. We hope to present results in 2028-2029.