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Study of BI 690517 and empagliflozin combination for protection of heart and kidneys in patients with chronic kidney disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial 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

  2. Step 2

    Monitoring 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

  3. Step 3

    Long-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

  4. Step 4

    Health 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 trial?

5 criteria

  • 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 trial?

18 criteria

  • 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
  • Uncontrolled diabetes mellitus (blood sugar disease)
  • Severe liver disease
  • Recent heart attack or stroke (within the last 3 months)
  • Active cancer or ongoing cancer treatment
  • History of organ transplantation
  • Severe uncontrolled high blood pressure
  • Serious infections that require hospitalization
  • Blood disorders that increase risk of bleeding
  • Unable to take medications by mouth
  • Mental conditions that could interfere with following study procedures
  • Alcohol or drug abuse within the past 6 months
  • Life expectancy less than 12 months due to other medical conditions
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Investigated drugs

  • 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.

What is already known about the treatment

  • BI 690517

    An investigational aldosterone synthase inhibitor administered orally once daily, currently being studied in clinical trials for chronic kidney disease treatment. This medication works by blocking the enzyme responsible for aldosterone production, which plays a key role in kidney function and blood pressure regulation. It is being tested in combination with empagliflozin to evaluate its potential in preventing kidney disease progression and reducing cardiovascular complications.

  • Empagliflozin

    An oral medication from the SGLT2 inhibitor class that works by helping the kidneys remove excess sugar from the blood through urination. This established medication is approved for treating type 2 diabetes and heart failure, and is being studied in combination with BI 690517 for chronic kidney disease management. It functions by blocking glucose reabsorption in the kidneys, which may help reduce kidney stress and improve cardiovascular outcomes.

Investigated diseases

  • 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.

Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511025-63-00Protocol code1378-0006Estimated enrolment11 650 patientsSponsorBoehringer Ingelheim International GmbH

sourced from the EU Clinical Trials Register and site verification

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