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A study testing finerenone compared to placebo in patients with chronic kidney disease who are not taking renin-angiotensin-system inhibitors

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What is this trial about?

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

This study involves people with chronic kidney disease who are not currently taking certain blood pressure medications that affect the kidneys. Chronic kidney disease is a condition where the kidneys gradually lose their ability to filter waste and excess fluid from the blood. The study will compare the effects of finerenone, which is also called BAY 94-8862, with placebo. Finerenone is a medication given as a film-coated tablet that is taken by mouth.

The purpose of the study is to find out if finerenone is better than placebo in reducing the amount of protein in the urine over six months. Protein in the urine is a sign that the kidneys are not working properly. The study will also look at the safety of finerenone by checking for side effects and monitoring potassium levels in the blood, as high potassium can be a concern with this type of medication.

Participants in this study will be randomly assigned to receive either finerenone or placebo for a treatment period that can last up to 175 days. During the study, participants will have regular check-ups where doctors will measure the protein levels in their urine and monitor their overall health. The study is designed to be double-blind, which means that neither the participants nor the doctors will know who is receiving finerenone and who is receiving placebo until the study is completed.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and treatment assignment

    After joining the study, you will be randomly assigned to one of two treatment groups. This process is called randomization and works like flipping a coin to determine which group you will be in.

    You will receive either finerenone (the medication being tested) or placebo (an inactive substance that looks like the medication but contains no active ingredient).

    Neither you nor your doctor will know which treatment you are receiving. This is called a double-blind study and helps ensure the results are accurate.

  2. Step 2

    Taking the study medication

    You will take the assigned medication by mouth in the form of film-coated tablets.

    The study will evaluate the effects of finerenone compared to placebo over a period of 6 months.

    Your doctor will provide specific instructions on how often to take the medication and what dose to use.

  3. Step 3

    Regular monitoring visits

    Throughout the study, you will attend regular visits at the study site.

    During these visits, your kidney function will be monitored by measuring eGFR (a calculation that shows how well your kidneys are filtering waste) and UACR (a urine test that measures the amount of protein in your urine, which indicates kidney health).

    Your potassium level will be checked regularly through blood tests to ensure it stays within a safe range.

    The study team will monitor for any side effects or health changes that may occur during treatment.

  4. Step 4

    Assessment at 6 months

    At the 6-month mark, the main assessment will be performed to measure changes in your UACR (urine protein levels) compared to the beginning of the study.

    This measurement helps determine whether the medication is effective in reducing protein in your urine, which is a sign of improved kidney function.

  5. Step 5

    Safety monitoring throughout the study

    Throughout the entire study period, any side effects or health problems you experience will be recorded and evaluated.

    Special attention will be given to monitoring for hyperkalemia, which means having too much potassium in your blood.

    Any serious health events will be carefully documented and assessed by the study team.

  6. Step 6

    Completion of the study

    The study is expected to continue until the end of 2027.

    After completing your participation, final assessments will be performed to evaluate your overall health and the effects of the treatment you received.

Who can join the trial?

6 criteria

  • You must be at least 18 years old or the legal age to give consent in your area at the time of signing the consent form.
  • Your potassium level (a mineral in your blood) must be 5.0 or lower at the screening visit.
  • You must have a medical diagnosis of chronic kidney disease (long-term kidney problems) and meet both of these requirements: Your eGFR (a blood test that shows how well your kidneys are filtering waste) must be between 25 and 120; and Your UACR (a urine test that measures protein in your urine) must be between 100 and 5000, and you must have had high levels of protein in your urine documented in your medical records at least 3 months before the screening visit.
  • You must not be currently taking or have taken in the past 8 weeks any medicines called RAS inhibitors (medications that help control blood pressure and protect the kidneys, such as ACE inhibitors, ARBs, or Renin inhibitors like Aliskiren).
  • You can be male or female.
  • You must be able to understand and sign the consent form, and be willing to follow all the requirements of the study.

Who cannot join the trial?

11 criteria

  • Pregnant women or women who are breastfeeding cannot participate in this study
  • People who are allergic (have a bad reaction) to finerenone or any ingredient in the study medicine
  • People with severe kidney problems who need dialysis (a treatment that cleans the blood when kidneys cannot do this job)
  • People with very high levels of potassium (a mineral in your blood) in their blood
  • People who are already taking RAS inhibitors (medicines that help control blood pressure and protect the kidneys)
  • People with severe liver disease (serious problems with the organ that cleans toxins from your body)
  • People who have had a heart attack (when blood flow to the heart is blocked) or stroke (when blood flow to the brain is blocked) in the last month
  • People with heart failure (when the heart cannot pump blood well enough) that is not stable or controlled
  • People taking certain medicines that can interact badly with the study medicine, including some antifungal medicines (medicines that treat fungal infections) and some medicines for HIV (a virus that affects the immune system)
  • People who cannot follow the study requirements or attend regular visits
  • People participating in another clinical trial at the same time
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Investigated drugs

Finerenone is a medication being tested in this study for people with chronic kidney disease. It works by blocking certain hormones that can cause damage to the kidneys. The researchers want to see if this medication can help reduce protein levels in the urine, which is a sign of kidney damage, compared to a placebo (a dummy pill with no active medication).

What is already known about the treatment

Finerenone – Finerenone is a medication taken by mouth in tablet form that is being studied for treating chronic kidney disease in patients who are not taking certain blood pressure medications called RAS inhibitors. It works by blocking a specific protein receptor in the body called the mineralocorticoid receptor, which helps reduce inflammation and scarring in the kidneys. This drug belongs to a class of medicines known as non-steroidal mineralocorticoid receptor antagonists and is currently approved in some countries for kidney disease treatment, while this trial is investigating its use in a specific patient group. The main goal is to see if finerenone can reduce the amount of protein in the urine, which is a sign of kidney damage, better than a placebo over a six-month period.

Investigated diseases

Chronic Kidney Disease – Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. The disease develops slowly over months or years, often without noticeable symptoms in the early stages. As the condition progresses, waste products build up in the body, leading to various health problems. The kidneys become less effective at maintaining the balance of minerals and fluids in the body. Over time, the damage to the kidneys becomes permanent and can worsen if left unmanaged. The disease typically advances through five stages, with each stage representing a further decline in kidney function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523075-32-00Protocol code22817Estimated enrolment180 patientsSponsorUniversitair Medisch Centrum Groningen

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