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Study on the Effectiveness and Safety of Finerenone for Patients with Chronic Kidney Disease and Type 1 Diabetes

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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 called finerenone on people who have a long-term decrease in their kidneys' ability to work properly, known as chronic kidney disease, along with type 1 diabetes. The study aims to find out how well finerenone works and how safe it is when used in addition to the usual care for these conditions. Finerenone is taken as a film-coated tablet and is being compared to a placebo, which looks like the real medication but does not contain the active substance.

The purpose of the study is to see if finerenone can help reduce a specific measure related to kidney function over a period of six months. Participants in the study will be randomly assigned to receive either finerenone or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The study will take place over several months, and participants will continue to receive their standard care for chronic kidney disease and type 1 diabetes while participating in the trial.

Throughout the study, researchers will monitor participants for any changes in their kidney function and any side effects that may occur. The main focus will be on changes in a specific kidney-related measure, and researchers will also keep track of any adverse events, including any significant increases in potassium levels, which is a potential side effect of the treatment. The study is designed to provide valuable information about the potential benefits and safety of finerenone for people with chronic kidney disease and type 1 diabetes.

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, you will be randomly assigned to receive either the study medication, finerenone, or a placebo. A placebo looks like the study medication but does not contain the active ingredient.

    The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are unbiased.

  2. Step 2

    Medication administration

    You will take the assigned medication in the form of a film-coated tablet by mouth. The exact dosage and frequency will be provided by the study team.

    The medication will be taken in addition to your standard care for chronic kidney disease and type 1 diabetes.

  3. Step 3

    Study duration

    The study will last for approximately 6 months. During this time, you will continue to take the medication as instructed.

    Regular check-ups will be scheduled to monitor your health and the effects of the medication.

  4. Step 4

    Health assessments

    Throughout the study, your health will be closely monitored. This includes measuring your UACR (urinary albumin-to-creatinine ratio) to assess kidney function.

    You will also be monitored for any side effects, including hyperkalaemia (high potassium levels in the blood).

  5. Step 5

    End of study

    At the end of the study, a final assessment will be conducted to evaluate the effects of the medication on your condition.

    The study team will discuss the results with you and provide guidance on any further steps.

Who can join the trial?

7 criteria

  • Participant must be at least 18 years old at the time of signing the consent form.
  • Participants must have Type 1 Diabetes (T1D), which means they have been continuously treated with insulin, starting within one year from their diagnosis.
  • The HbA1c level, which is a measure of blood sugar control over the past 2-3 months, must be less than 10% at the screening. If the first test result is missing or invalid, one retest is allowed.
  • The level of potassium (K+) in the blood must be 4.8 mmol/L or lower at the screening.
  • Participants must have a clinical diagnosis of Chronic Kidney Disease (CKD) and meet both of these criteria:
    • The eGFR (estimated Glomerular Filtration Rate), which measures kidney function, must be between 25 and 90 mL/min/1.73 m² at the screening.
    • The UACR (Urine Albumin-to-Creatinine Ratio), which measures protein in the urine, must be between 200 mg/g and 5000 mg/g at the screening, based on the average of three measurements.
    • Participants must be on a stable treatment with either an ACEI (Angiotensin-converting enzyme inhibitor) or an ARB (Angiotensin receptor blocker) for at least four weeks before the screening, preferably without any change in dosage.

Who cannot join the trial?

9 criteria

  • Patients with any other serious medical condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a kidney transplant.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of severe allergic reactions to the study medication.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver disease.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

Finerenone is a medication being studied for its potential to help people with chronic kidney disease and type 1 diabetes. It works by blocking certain receptors in the body that can contribute to kidney damage. The goal of using finerenone in this trial is to see if it can reduce the amount of protein in the urine, which is a sign of kidney damage, over a period of six months. This medication is being tested to see if it can provide better results than the standard treatments currently available.

What is already known about the treatment

Finerenone – Finerenone is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating chronic kidney disease associated with type 1 diabetes. It is not yet widely available in medical practice as it is still under investigation. The main therapeutic indication for finerenone is to help reduce the levels of a protein called albumin in the urine, which is a marker of kidney damage. At the molecular level, finerenone works by blocking certain receptors in the body that are involved in the progression of kidney disease. It belongs to a class of drugs known as mineralocorticoid receptor antagonists, which help protect the kidneys from further damage.

Investigated diseases

Chronic kidney disease associated with type 1 diabetes mellitus – This condition involves the gradual loss of kidney function in individuals who have type 1 diabetes. Over time, high blood sugar levels can damage the blood vessels in the kidneys, leading to impaired kidney function. As the disease progresses, the kidneys become less effective at filtering waste and excess fluids from the blood. This can result in the accumulation of waste products in the body, causing symptoms such as fatigue, swelling, and changes in urination. The progression of the disease can vary, but it typically involves a slow decline in kidney function over several years. Regular monitoring and management of blood sugar levels are crucial to slowing the progression of kidney damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-503024-27-00Protocol code22267Estimated enrolment220 patientsSponsorBayer AG

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