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Study on the Effectiveness and Safety of Finerenone for Adults with Non-Diabetic 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 in patients with non-diabetic chronic kidney disease. Chronic kidney disease is a condition where the kidneys gradually lose their ability to filter waste from the blood. The study aims to determine if Finerenone, when added to the usual care, can slow down the progression of kidney disease compared to a placebo.

Participants in the study will receive either Finerenone or a placebo, in addition to their standard treatment. The medication is taken orally in the form of a film-coated tablet. The study will monitor the participants over a period to observe any changes in their kidney function and overall health. The main goal is to see if Finerenone can delay the worsening of kidney disease.

Throughout the study, researchers will also keep track of any side effects or health issues that may arise. The study is designed to provide valuable information on the safety and effectiveness of Finerenone for people with non-diabetic chronic kidney disease, potentially offering a new option for managing this condition.

The research process

The trial runs in 5 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 randomly assigned to receive either the medication finerenone or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

    The study is designed to assess the effectiveness and safety of finerenone in slowing the progression of kidney disease in individuals with non-diabetic chronic kidney disease.

  2. Step 2

    Medication administration

    Participants will take the assigned medication orally in the form of a film-coated tablet. The specific dosage and frequency will be determined by the study protocol and communicated to the participant at the start of the trial.

    The medication will be taken in addition to the participant's standard care, which includes a stable and maximum tolerated dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB).

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will undergo regular monitoring to assess kidney function and overall health. This includes measuring the estimated glomerular filtration rate (eGFR) and urine albumin/creatinine ratio (UACR).

    Participants will also be monitored for any adverse events or side effects related to the treatment.

  4. Step 4

    Study duration

    The study is expected to last until February 2026, with participants being followed for a period of up to 32 months from the start of their participation.

    The primary goal is to measure the change in kidney function over time, specifically the rate of change in eGFR.

  5. Step 5

    End of study

    At the conclusion of the study, participants will have a final assessment to evaluate the overall impact of the treatment on kidney disease progression.

    The results will contribute to understanding the effectiveness and safety of finerenone in treating non-diabetic chronic kidney disease.

Who can join the trial?

8 criteria

  • You must have a clinical diagnosis of **chronic kidney disease**. This means your kidneys are not working as well as they should for a long time, but it is not caused by diabetes.
  • Your **urine albumin/creatinine ratio (UACR)** should be between 200 and 3500 mg/g. This is a test that checks for protein in your urine, which can be a sign of kidney problems.
  • Your **estimated glomerular filtration rate (eGFR)** should be between 25 and 90 mL/min/1.73m². This is a test that measures how well your kidneys are filtering your blood.
  • You need to have a record of **albuminuria/proteinuria** in your medical records at least 3 months before the screening. This means there should be a history of protein in your urine.
  • You should be on a stable and maximum tolerated dose of an **Angiotensin converting enzyme inhibitor (ACEI)** or **Angiotensin receptor blocker (ARB)** for at least 4 weeks before the screening. These are medications that help control blood pressure and protect the kidneys.
  • Your **potassium (K+)** level should be 4.8 mmol/L or lower at screening. Potassium is a mineral in your blood that needs to be at a safe level.
  • Both men and women can participate in the study.
  • The study includes people who are considered part of a vulnerable population, meaning they might need extra protection or care.

Who cannot join the trial?

10 criteria

  • Patients with **diabetes** cannot participate. **Diabetes** is a condition where the body has trouble managing sugar levels.
  • Patients with **severe liver disease** are excluded. **Liver disease** affects how the liver works, which is important for overall health.
  • Patients who have had a **kidney transplant** cannot join. A **kidney transplant** is when a person receives a new kidney from a donor.
  • Patients with **uncontrolled high blood pressure** are not eligible. **High blood pressure** means the force of blood against the artery walls is too high.
  • Patients who are **pregnant or breastfeeding** cannot participate. **Pregnant** means expecting a baby, and **breastfeeding** means feeding a baby with milk from the breast.
  • Patients with a history of **allergic reactions** to similar medications are excluded. An **allergic reaction** is when the body reacts badly to a substance.
  • Patients currently participating in another clinical trial are not eligible. This means they are already part of a different study.
  • Patients with **severe heart failure** cannot join. **Heart failure** is when the heart doesn't pump blood as well as it should.
  • Patients with **active cancer** are excluded. **Active cancer** means the cancer is currently growing or spreading.
  • Patients with **severe lung disease** cannot participate. **Lung disease** affects how well the lungs work, which is important for breathing.
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Investigated drugs

Finerenone is a medication being studied for its ability to slow down the progression of kidney disease in patients who do not have diabetes. It is being tested to see if it can provide additional benefits when used alongside the standard treatments that patients are already receiving for their kidney condition.

What is already known about the treatment

Finerenone – Finerenone is administered orally in tablet form and is currently being studied in a Phase 3 clinical trial for its effectiveness in treating non-diabetic chronic kidney disease. It is a mineralocorticoid receptor antagonist, which means it works by blocking certain receptors in the body that can contribute to kidney damage. This medication is classified as a diuretic and is being evaluated for its potential to slow the progression of kidney disease when used alongside standard care treatments.

Investigated diseases

Non-diabetic chronic kidney disease – This condition involves the gradual loss of kidney function over time in individuals who do not have diabetes. The kidneys become less effective at filtering waste and excess fluids from the blood, which can lead to a buildup of harmful substances in the body. As the disease progresses, symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns may occur. The progression of the disease can vary, with some individuals experiencing a slow decline in kidney function, while others may see a more rapid deterioration. The condition can eventually lead to kidney failure, requiring dialysis or a kidney transplant. Regular monitoring and lifestyle adjustments are often necessary to manage the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506897-11-00Protocol code21177Estimated enrolment1 584 patientsSponsorBayer AG

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