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. This study has 2 parts. In the first part, participants get empagliflozin or placebo matching BI 690517 for at least 6 weeks. All participants continue taking ACEi or ARB throughout the study. In the second part, participants are put into 2 groups by chance. One group takes BI 690517 tablets and the other group takes placebo tablets. Placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants take a tablet once a day for the time 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.