EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)

This study is looking for adults aged 18 or over. You might be able to take part if you have chronic kidney disease, which means your kidneys aren't working perfectly, and there is a risk that your kidney health could worsen. This is typically measured by specific blood and urine tests.

You can still join if you have type 2 diabetes or if you don’t. You might also be eligible if you are currently taking medicines for kidney protection like ACE inhibitors (ACEi) or ARBs, or even if you are already on empagliflozin or similar medications. The study also welcomes people who are not currently taking any of these types of treatments.

However, there are some reasons why you might not be able to join. For example, if your potassium levels are too high, or you have certain liver conditions. You also can’t join if you are currently on dialysis, have recently had a kidney transplant, or are already taking certain other specific kidney medications. The medical team will check all these details carefully.

If you join the study, it will be split into two main parts. In the first part, which lasts at least 6 weeks, everyone will receive either empagliflozin or a dummy pill that looks like BI 690517. If you're already taking other kidney-protective medicines like ACE inhibitors or ARBs, you'll continue to do so throughout the study if your doctor thinks you should.

In the second part, you'll be randomly assigned to one of two groups. One group will take the new medicine, BI 690517, as a tablet once a day, alongside empagliflozin. The other group will take a dummy pill (placebo) that looks identical but contains no medicine, also once a day, along with empagliflozin. You won't know whether you're taking the active new medicine or the dummy pill, and neither will the study doctors.

The study is expected to last about 3 to 4 years. Over the first 6 months, you'll visit the study clinic about 4 times. After that, you'll visit every 6 months until the end of the study. At these visits, doctors will regularly check your overall health, measure your blood pressure and weight, take blood and urine samples to check your kidney function, and ask about any new symptoms or side effects you might be experiencing.