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Study on the Long-Term Safety of Finerenone with ACE Inhibitors or ARBs for Children and Young Adults with Chronic Kidney Disease and Proteinuria

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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 safety of a medication called finerenone in children and young adults aged 1 to 18 years who have chronic kidney disease and a condition called proteinuria, which means there is an excess of protein in the urine. The study will explore how safe it is to use finerenone over a long period when taken alongside another type of medication, either an ACE inhibitor or an angiotensin receptor blocker (ARB). These medications are commonly used to help manage blood pressure and protect the kidneys.

Participants in the study will take finerenone in the form of either a film-coated tablet or granules for oral suspension, depending on their age and body weight. The study will last for 18 months, during which time the participants will continue their usual treatment with an ACE inhibitor or ARB. The goal is to ensure that adding finerenone to their treatment is safe over this extended period.

Throughout the study, researchers will monitor the participants for any side effects and changes in their health, such as variations in blood pressure and potassium levels. The study aims to provide valuable information on the long-term safety of finerenone for young patients with chronic kidney disease and proteinuria, helping to improve treatment options for this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    The study involves children and young adults aged 1 to 18 years with chronic kidney disease and proteinuria.

    Participants must have previously participated in the finerenone Phase 3 study FIONA and not have been permanently discontinued from treatment.

    Participants must be treated with an ACE inhibitor or angiotensin receptor blocker at optimized doses for at least 30 days prior to joining.

  2. Step 2

    Medication administration

    The study involves taking finerenone, which is available as a film-coated tablet or granules for oral suspension.

    The medication is taken orally, and the dosage is adjusted based on age and body weight.

    The treatment is administered in addition to an ACE inhibitor or angiotensin receptor blocker.

  3. Step 3

    Treatment duration

    The study lasts for 18 months.

    The primary goal is to assess the safety of long-term use of finerenone in combination with other medications.

  4. Step 4

    Monitoring and assessments

    Participants will be monitored for treatment emergent adverse events.

    Changes in serum potassium levels and systolic blood pressure will be measured from the start of the study to Day 540.

    Secondary assessments include changes in urinary protein-to-creatinine ratio, urinary albumin-to-creatinine ratio, and estimated glomerular filtration rate.

Who can join the trial?

6 criteria

  • Participants must be between 1 year and 18 years old at the time of signing the consent form.
  • Participants should have previously taken part in the finerenone Phase 3 study called FIONA and should not have been permanently stopped from treatment by the end of that study.
  • Participants must have a clinical diagnosis of chronic kidney disease (CKD) at the first visit. CKD stages 1-3 mean the kidneys are not working as well as they should, but not severely. This is measured by a test called estimated glomerular filtration rate (eGFR), which should be 30 or more for children aged 1 to under 19 years at the end of the FIONA study and at the first visit.
  • Participants must be treated with a type of medicine called an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at the highest dose they can handle, according to guidelines for managing blood pressure. This treatment should not have changed for at least 30 days before the first visit.
  • The level of potassium (K+) in the blood should be 5.0 or less for children aged 2 years and older, and 5.3 or less for children under 2 years, at both the end of the FIONA study and the first visit.
  • Participants must be able to receive food through normal eating, bottle or cup feeding, or through feeding tubes, with or without breastfeeding.

Who cannot join the trial?

5 criteria

  • Children who do not have chronic kidney disease with proteinuria cannot participate. Proteinuria means having too much protein in the urine, which can be a sign of kidney problems.
  • Children who are not in the age range of 2 to 3 years old cannot participate.
  • Children who are not able to take medications called ACEI or ARB cannot participate. These are types of medicines that help control blood pressure and protect the kidneys.
  • Children who have any other medical conditions that might interfere with the study cannot participate.
  • Children who are not able to follow the study procedures or take the study medication as directed cannot participate.
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Investigated drugs

  • Finerenone

    is a medication being studied for its safety when used long-term in children and young adults with chronic kidney disease and proteinuria. It is taken orally and is adjusted based on age and body weight. The goal is to see if it can be safely added to other treatments for kidney disease.

  • ACEI (Angiotensin-Converting Enzyme Inhibitors)

    are medications that help relax blood vessels and reduce blood pressure. They are commonly used to treat conditions like high blood pressure and heart failure. In this study, they are used alongside finerenone to manage chronic kidney disease.

  • ARB (Angiotensin II Receptor Blockers)

    are another type of medication that helps lower blood pressure by blocking the action of a natural chemical that narrows blood vessels. Like ACEIs, ARBs are used in this study with finerenone to treat chronic kidney disease in young patients.

What is already known about the treatment

Finerenone – Finerenone is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating children and young adults with chronic kidney disease and proteinuria. It is used in combination with ACE inhibitors or ARBs. The medication is classified as a non-steroidal mineralocorticoid receptor antagonist. It works by blocking the effects of aldosterone, a hormone that can contribute to kidney damage, thereby reducing inflammation and fibrosis in the kidneys. Finerenone is being evaluated for its long-term safety in this patient population.

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. This can lead to a buildup of waste products in the body, causing symptoms like fatigue, swelling, and changes in urination. Over time, the disease can progress to more severe stages, potentially affecting other organs and systems. The progression is often slow, and symptoms may not appear until significant kidney damage has occurred. Management focuses on slowing the progression and addressing symptoms.

  • Proteinuria

    Proteinuria is a condition characterized by the presence of excess protein in the urine, which can be a sign of kidney damage. Normally, kidneys filter waste while retaining essential proteins in the blood, but when damaged, they may allow proteins to leak into the urine. This condition can be a result of various underlying health issues, including chronic kidney disease. It may not cause noticeable symptoms initially, but over time, it can lead to swelling and other complications. Monitoring and managing proteinuria is crucial to prevent further kidney damage.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504885-50-00Protocol code20186Estimated enrolment109 patientsSponsorBayer AG

sourced from the EU Clinical Trials Register and site verification

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