A Multicenter, International, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Aldosterone Synthase Inhibitor BI 690517 in Combination With Empagliflozin in Patients With Chronic Kidney Disease

This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for heart disease. After a run-in period, during which participants are confirmed to be receiving clinically appropriate renin-angiotensin system blockade and are established on empagliflozin, they are randomly assigned (by chance) to 1 of 2 groups. One group receives BI 690517 tablets, and the other group receives placebo tablets. Placebo tablets look like BI 690517 but do not contain any medicine. Participants take 1 study tablet once a day, in addition to empagliflozin, for the duration of the study. The doctors document when participants experience worsening of their kidney disease, must go to hospital due to heart failure, or die during the study. The time to these events is compared between the treatment groups to see whether the treatment works. The study continues until the required number of events have occurred which is about 3 to 4 years. During this time, participants visit the study site 4 times within the first 6 months. Then they visit the study site every half a year. At the visits doctors regularly check participants' health, take blood and urine samples, do physical exams, check kidney function, and take note of any unwanted effects. To definitively test the efficacy and safety of BI 690517 given on top of standard of care, including empagliflozin in participants with established CKD, at risk of kidney disease progression Whether taking a BI 690517 pill once a day compared to an inactive pill (placebo), in combination with an empagliflozin pill, prevents worsening of kidney disease, hospitalisation for heart failure, or death from heart disease in people with kidney disease.