This clinical trial focuses on chronic kidney disease and tests a combination of two medications. The first medication is BI 690517, an aldosterone synthase inhibitor, and the second is empagliflozin (also known as Jardiance), which belongs to a group of medicines called SGLT2 inhibitors. The study aims to determine if taking BI 690517 daily together with empagliflozin can help prevent the worsening of kidney disease, reduce hospitalizations due to heart problems, or prevent death from heart disease in people with kidney disease.
The study uses film-coated tablets that participants take by mouth. Some participants will receive BI 690517 together with empagliflozin, while others will receive a placebo tablet together with empagliflozin. The treatment period will last for up to 48 months. The study is designed to be double-blind, which means neither the participants nor the doctors know who receives which treatment.
During the study, doctors will monitor kidney function and heart health through regular medical examinations. They will track any changes in kidney function, instances of hospitalization, and other important health events. This information will help determine how effective the combination of medications is in protecting both the kidneys and heart in people with chronic kidney disease.
1Initial medication phase
You will receive two medications: empagliflozin (Jardiance) 10 mg tablet and BI 690517 or placebo tablet
Both medications are taken orally (by mouth) once daily
One tablet is a film-coated tablet containing either BI 690517 or an inactive substance (placebo)
The other tablet contains empagliflozin, which all participants will receive
2Monitoring kidney function
Your kidney function will be regularly measured through a value called eGFR (estimated glomerular filtration rate)
The first important measurement will be taken 3 months after starting the medication
Regular measurements will continue until your last scheduled visit
3Long-term follow-up
The study will continue until July 2028
During this time, you will be monitored for:
Changes in kidney disease status
Any hospital stays related to heart failure
Overall cardiovascular health
4Health monitoring
The medical team will track if your kidney function decreases by 40% or more from your starting point
Any hospital stays will be recorded, particularly those related to heart problems
Your overall heart health will be monitored throughout the study period
Who Can Join the Study?
You must be at least 18 years old at the time of screening
You must have evidence of chronic kidney disease that shows risk of progression, documented by laboratory tests from at least 3 months before screening and at the screening visit
You must meet one of these kidney function criteria:
Your kidney function test (eGFR) shows results between 20 and 45 units (mL/min/1.73m²), or
Your kidney function test (eGFR) shows results between 45 and 90 units (mL/min/1.73m²) with elevated protein levels in urine (uACR of at least 200 mg/g or protein-to-creatinine ratio of at least 300 mg/g)
Both men and women can participate in the study
Who Cannot Join the Study?
Age below 18 years
Severe allergic reactions to empagliflozin (a diabetes medication) or similar medications
Pregnancy or planning to become pregnant during the study period
Currently breastfeeding
Participation in another clinical trial within the past 30 days
History of serious kidney problems requiring dialysis
BI 690517 is an aldosterone synthase inhibitor medication being tested to help prevent the worsening of kidney disease, reduce hospitalizations due to heart failure, and lower the risk of death from heart disease in people with kidney problems. This medication is taken as a daily pill.
Empagliflozin is a medication used to treat diabetes and heart failure. In this trial, it is being used in combination with BI 690517. It belongs to a class of medications called SGLT2 inhibitors, which work by helping the kidneys remove excess sugar from the blood through urine and can help protect both the heart and kidneys.
Chronic kidney disease – A long-term condition where the kidneys gradually lose their ability to filter waste and excess fluid from the blood. The disease typically develops over many years as the tiny filters in the kidneys become damaged. This condition often progresses through several stages, from mild kidney damage to severe loss of kidney function. Common signs include changes in urination, swelling in legs and ankles, and fatigue. The disease can be associated with other health conditions such as high blood pressure and diabetes.
Heart failure – A chronic condition where the heart cannot pump blood effectively enough to meet the body’s needs. The heart muscle becomes weaker over time or has difficulty filling with blood. This leads to fluid buildup in the body, particularly in the lungs and extremities. Common symptoms include shortness of breath, fatigue, and swelling in the legs and ankles.
Cardiovascular disease – A group of conditions affecting the heart and blood vessels throughout the body. The disease typically develops when arteries become narrowed or blocked by fatty deposits. This process happens gradually over time and can affect blood flow to various parts of the body. The condition can involve multiple parts of the cardiovascular system and may progress differently in different people.
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