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Study on the Effectiveness and Safety of Finerenone and Empagliflozin in Adults with Chronic Kidney Disease and Type 2 Diabetes

Fast replyRegistered drugNo placebo
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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 treatment combination for people with chronic kidney disease and type 2 diabetes. The study will evaluate how well the combination of two medications, finerenone and empagliflozin, works compared to each medication taken alone. Finerenone is a type of medication known as a mineralocorticoid receptor antagonist, which helps to reduce the effects of certain hormones that can harm the kidneys. Empagliflozin is a medication that helps lower blood sugar levels by helping the kidneys remove glucose from the bloodstream.

The purpose of the study is to determine if the combination of these two medications is more effective in reducing a specific measure related to kidney function, known as the urinary albumin-to-creatinine ratio, than taking either medication alone. Participants in the study will be randomly assigned to one of three groups: one group will receive both finerenone and empagliflozin, another group will receive only finerenone, and the third group will receive only empagliflozin. Some participants may receive a placebo, which looks like the medication but does not contain the active ingredient.

The study will last for about six months, during which participants will take the assigned medication daily. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The goal is to gather information on the safety and effectiveness of the treatment combination, which could lead to better management of chronic kidney disease in people with type 2 diabetes.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be informed about the trial's purpose, which is to evaluate the effectiveness and safety of the combination of finerenone and empagliflozin compared to each drug alone in individuals with chronic kidney disease and type 2 diabetes.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying a diagnosis of chronic kidney disease and type 2 diabetes, as well as ensuring the participant is on a stable dose of either an ACE inhibitor or an angiotensin receptor blocker.

  3. Step 3

    Medication administration

    Participants will be randomly assigned to one of three groups: receiving finerenone (either 10 mg or 20 mg), empagliflozin (10 mg), or a combination of both. All medications are taken orally in the form of film-coated tablets.

  4. Step 4

    Treatment duration

    The treatment will last for 180 days. During this period, participants will take their assigned medication daily as instructed.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, participants will undergo regular monitoring to assess changes in urinary albumin to creatinine ratio (UACR) and other health parameters. This includes visits at specified intervals to evaluate the treatment's impact and any potential side effects.

  6. Step 6

    End of treatment evaluation

    At the end of the 180-day treatment period, a final evaluation will be conducted to measure the primary outcomes, including changes in UACR and kidney function.

  7. Step 7

    Post-treatment follow-up

    A follow-up assessment will occur 30 days after the end of treatment to observe any lasting effects or changes in health status.

Who can join the trial?

8 criteria

  • The participant must have a clinical diagnosis of chronic kidney disease (CKD). This means their kidneys are not working as well as they should.
  • For Part A of the study, the participant's eGFR (a test that measures kidney function) should be between 40-90 ml/min/1.73m². No more than 20% of participants can have an eGFR greater than 75 ml/min/1.73m². They should also have a past eGFR value of less than 60 ml/min/1.73m² within the last 3 months or a registered diagnosis of CKD.
  • For Part B of the study, the participant's eGFR should be between 30-90 ml/min/1.73m², with the same conditions as Part A regarding the percentage of participants and past eGFR values.
  • The participant's UACR (a test that measures the amount of albumin in the urine) should be between 100 and 5000 mg/g at the screening visit. This is based on the average of three morning urine samples. They should also have documentation of albuminuria or proteinuria (presence of protein in urine) in their medical records at least 3 months before the screening.
  • The participant must have type 2 diabetes (T2D), as defined by the American Diabetes Association, with a glycated hemoglobin (HbA1c) level of less than 11% at the screening. HbA1c is a blood test that shows average blood sugar levels over the past 2-3 months.
  • The participant should be treated with the highest dose they can tolerate of either an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for more than 1 month before the screening visit. These are medications used to treat high blood pressure and protect the kidneys.
  • Participants can be of any gender.
  • The study includes participants who may be considered vulnerable.

Who cannot join the trial?

8 criteria

  • Patients with severe liver disease cannot participate. This means if your liver is not working well, you may not be eligible.
  • Patients with a history of heart attack or stroke in the last 6 months are excluded. This means if you had a heart attack or stroke recently, you cannot join.
  • Patients with uncontrolled high blood pressure are not allowed. This means if your blood pressure is very high and not managed well, you cannot take part.
  • Patients who are pregnant or breastfeeding cannot participate. This means if you are expecting a baby or nursing, you are not eligible.
  • Patients with a history of severe allergic reactions to the study drugs are excluded. This means if you had a bad allergy to similar medications, you cannot join.
  • Patients with certain types of cancer are not allowed. This means if you have cancer that is not well controlled, you cannot participate.
  • Patients with severe kidney disease not related to diabetes are excluded. This means if your kidney problems are not because of diabetes, you cannot join.
  • Patients who are currently participating in another clinical trial are not allowed. This means if you are already in a different study, you cannot take part in this one.
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Investigated drugs

Finerenone is a medication used in this trial to help manage chronic kidney disease in people with type 2 diabetes. It works by blocking certain receptors in the body that can lead to kidney damage. The goal is to see if it can reduce the amount of protein in the urine, which is a sign of kidney health. Empagliflozin is another medication being tested in the trial. It is used to help control blood sugar levels in people with type 2 diabetes and also has benefits for kidney health. It works by helping the kidneys remove sugar from the body through urine, which can also help protect the kidneys. The trial is also testing the combination of Finerenone and Empagliflozin together to see if using both medications at the same time is more effective in reducing kidney damage than using either medication alone. The combination aims to provide better protection for the kidneys by using the different ways each medication works.

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 effectiveness in treating chronic kidney disease in individuals with type 2 diabetes. The medication works by blocking mineralocorticoid receptors, which helps reduce inflammation and fibrosis in the kidneys. It is classified as a non-steroidal mineralocorticoid receptor antagonist.

  • Empagliflozin

    Empagliflozin is taken orally as a tablet. It is approved for use in managing type 2 diabetes and is being investigated for its potential benefits in chronic kidney disease. The drug functions by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, leading to increased glucose excretion in urine and improved blood sugar control. It belongs to the class of SGLT2 inhibitors.

Investigated diseases

Chronic Kidney Disease in Type 2 Diabetes Mellitus – This condition occurs when the kidneys are damaged and cannot filter blood as well as they should, often due to the long-term effects of type 2 diabetes. Over time, the damage can worsen, leading to a gradual decline in kidney function. This progression can result in the accumulation of waste products in the blood, causing symptoms such as fatigue, swelling, and changes in urination. As the disease advances, it may lead to complications like high blood pressure and anemia. The progression of kidney damage can vary among individuals, influenced by factors such as blood sugar control and blood pressure management.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506981-30-00Protocol code21839Estimated enrolment807 patientsSponsorBayer AG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).