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Study on the Effects of Finerenone and SGLT2 Inhibitors on Heart and Kidney Health in Patients with Type 2 Diabetes and 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 is focused on studying the effects of a medication called finerenone on patients with type 2 diabetes and chronic kidney disease. The medication is also known by its code name, BAY 94-8862, and is taken as a film-coated tablet called Kerendia. The study aims to understand how this medication, when used in combination with another type of medication called sodium-glucose cotransporter-2 (SGLT2) inhibitors, affects the heart and kidneys in these patients.

Participants in the study will receive either the active medication or a placebo, which looks like the medication but does not contain the active ingredient. The study will observe changes in the heart and kidney health of participants over a period of time. This includes monitoring the heart's structure and function using a technique called magnetic resonance imaging (MRI), as well as measuring protein levels in urine to assess kidney function.

The trial will also look at other health indicators, such as blood pressure and certain markers in the blood and urine that are related to heart and kidney health. The goal is to determine if the combination of finerenone and SGLT2 inhibitors provides additional benefits in protecting the heart and kidneys compared to current treatments. The study is expected to continue until 2027, providing valuable insights into the management of type 2 diabetes and chronic kidney disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as having type 2 diabetes and chronic kidney disease.
Initial assessments include checking kidney function and other health parameters.
Step 2
Medication administration
Participants receive either Kerendia 10 mg film-coated tablets or a placebo. The medication is taken orally.
The treatment involves a combination of finerenone and sodium-glucose cotransporter-2 (SGLT2) inhibitors, which are already part of the participant's treatment plan.
Step 3
Monitoring and assessments
Regular monitoring includes measuring changes in heart and kidney function using MRI scans and blood tests.
Primary assessments focus on changes in heart muscle mass and kidney function, specifically albumin levels in urine.
Step 4
Secondary assessments
Additional tests evaluate heart function, blood pressure, and markers of inflammation and fibrosis.
Kidney health is further assessed through advanced imaging techniques and blood tests.
Step 5
Completion of the trial
The trial is expected to conclude by October 31, 2027.
Final assessments will determine the overall impact of the treatment on heart and kidney health.

Who can join the trial?

7 criteria

Have a diagnosis of type 2 diabetes as defined by the World Health Organization.
Have chronic kidney disease with specific kidney function levels (eGFR between 25-75 ml/min/1.73 m²) and high levels of a protein called albumin in the urine (urinary albumin-to-creatine ratio of 30-5000 mg/g).
Currently taking a medication called a sodium-glucose-cotransporter 2 (SGLT2) inhibitor at the highest dose you can tolerate. These medications help lower blood sugar levels.
Currently taking either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) at the highest dose you can tolerate. These medications help manage blood pressure and protect the kidneys.
Have a serum potassium level of 4.8 mmol/L or less at the time of screening. Potassium is a mineral in your blood that needs to be at a safe level.
Be over 18 years old.
Be able to speak and understand Danish fluently.

Who cannot join the trial?

4 criteria

Patients who do not have Type 2 diabetes or chronic kidney disease cannot participate. Type 2 diabetes is a condition where the body doesn't use insulin properly, and chronic kidney disease is when the kidneys are damaged and can't filter blood as well as they should.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
Patients who are not eligible based on other specific criteria set by the study cannot participate. These criteria are not detailed here.

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Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Finerenone
is a medication used in this trial to help protect the heart and kidneys in patients with type 2 diabetes. It works by blocking certain receptors in the body that can lead to damage in these organs. The goal is to see if it can reduce the risk of heart and kidney problems.
Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors
are a group of medications that help lower blood sugar levels in people with type 2 diabetes. They work by helping the kidneys remove sugar from the body through urine. In this trial, they are used in combination with finerenone to see if together they can provide better protection for the heart and kidneys.

Finerenone

What is already known about the treatment

Finerenone
Finerenone is administered orally in tablet form. It is currently being studied in clinical trials for its effects on heart and kidney health in patients with type 2 diabetes and chronic kidney disease. The main therapeutic use of Finerenone is to reduce the risk of heart and kidney complications in these patients. It works by blocking mineralocorticoid receptors, which helps to reduce inflammation and fibrosis in the heart and kidneys. Finerenone is classified as a non-steroidal mineralocorticoid receptor antagonist.
Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors
SGLT2 inhibitors are taken orally, usually in tablet form. They are well-established in medical practice for managing blood sugar levels in individuals with type 2 diabetes. These medications help lower blood sugar by preventing the kidneys from reabsorbing glucose back into the blood, thus promoting its excretion through urine. SGLT2 inhibitors are classified as antidiabetic agents and are also being explored for their potential benefits in heart and kidney health.

Investigated diseases

Type 2 Diabetes
This is a chronic condition that affects the way the body processes blood sugar (glucose). In type 2 diabetes, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or doesn't produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can lead to various complications, including damage to the eyes, kidneys, and nerves. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. Lifestyle factors such as obesity and inactivity are significant contributors to the development of type 2 diabetes.
Chronic Kidney Disease
This condition involves the gradual loss of kidney function over time. The kidneys filter waste and excess fluids from the blood, which are then excreted in urine. When chronic kidney disease reaches an advanced stage, dangerous levels of fluid, electrolytes, and wastes can build up in the body. Early stages may present with few symptoms, but as the disease progresses, symptoms such as nausea, vomiting, loss of appetite, fatigue, and changes in urination patterns may occur. The disease can be caused by conditions like diabetes and high blood pressure, which are the most common causes. Chronic kidney disease can lead to complications such as high blood pressure, anemia, and nerve damage.