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Study on Finerenone for Children with Chronic Kidney Disease and Proteinuria Using ACEI or ARB

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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 children with chronic kidney disease and proteinuria. Chronic kidney disease is a condition where the kidneys are damaged and cannot filter blood as well as they should, while proteinuria is the presence of excess protein in the urine, which can be a sign of kidney damage. The study will involve children aged 6 months to under 18 years who are already being treated with medications known as angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB), which help manage blood pressure and reduce kidney damage.

The purpose of the study is to evaluate how well finerenone works in reducing the amount of protein in the urine when used alongside ACEI or ARB. Participants will be randomly assigned to receive either finerenone or a placebo, which is a substance with no active medication. The study will last for six months, during which the children will take the medication in the form of film-coated tablets or granules for oral suspension, depending on their age and body weight. The study will monitor how the medication moves through the body and its effects on the body, including any side effects.

Throughout the study, researchers will collect information on changes in the urinary protein-to-creatinine ratio, which is a measure of protein levels in the urine. They will also track any side effects, changes in blood pressure, and kidney function. The study aims to determine if finerenone is more effective than a placebo in reducing protein levels in the urine, which could help improve kidney health in children with chronic kidney disease and proteinuria.

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 is required to have a clinical diagnosis of chronic kidney disease and proteinuria. The participant must be between 6 months and less than 18 years old.

    The participant must have stable kidney function and be treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses.

  2. Step 2

    Medication administration

    The participant will receive either finerenone or a placebo. Finerenone is administered in the form of 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.

  3. Step 3

    Treatment duration

    The treatment period lasts for 6 months. During this time, the participant will continue taking the medication as prescribed.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the participant's health will be monitored. This includes regular assessments of kidney function, protein levels in urine, and other relevant health indicators.

    The primary goal is to observe any reduction in urine protein excretion.

  5. Step 5

    End of study

    At the end of the 6-month period, the participant will undergo final assessments to evaluate the effects of the treatment.

    The study aims to determine the efficacy and safety of finerenone in reducing proteinuria in children with chronic kidney disease.

Who can join the trial?

9 criteria

  • Participants must be between 6 months and less than 18 years old when they sign the consent form.
  • Participants must have a clinical diagnosis of chronic kidney disease (CKD) at the start of the study. This means:
    • For children aged 1 year to less than 18 years, CKD stages 1-3, which means their kidneys are working at 30% or more of normal function.
    • For infants aged 6 months to less than 1 year, a blood test called serum creatinine must be 0.40 mg/dL or less.
    • Participants must have severely increased proteinuria, which means a high level of protein in the urine. This is measured by the urinary protein-to-creatinine ratio (UPCR):
      • For participants aged 2 years or older with CKD stage 2 and 3, UPCR must be 0.50 g/g or more.
      • For participants under 2 years of age or those 2 years and older with CKD stage 1, UPCR must be 1.0 g/g or more.
      • Participants must have stable kidney function between the start of the study and the first day of treatment. This means:
        • If their creatinine level is more than 0.8 mg/dL at the start, their kidney function should not change by 20% or more by the first day of treatment.
        • If their creatinine level is 0.8 mg/dL or less at the start, their creatinine should not change by 0.15 mg/dL or more by the first day of treatment.
        • Participants must be treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at the highest dose they can tolerate, according to guidelines for managing blood pressure. This treatment should not change for at least 30 days before the study starts.
        • Participants aged 2 years or older must have a potassium level of 5.0 mmol/L or less at both the start of the study and the first day of treatment. For children under 2 years, the potassium level must be 5.3 mmol/L or less at both times.

Who cannot join the trial?

2 criteria

  • Having a condition called proteinuria, which means there is too much protein in the urine.
  • Having chronic kidney disease, a long-term condition where the kidneys do not work as well as they should.
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Investigated drugs

  • Finerenone

    is a medication being studied for its ability to help reduce protein levels in the urine of children with chronic kidney disease. It is taken orally and is adjusted based on the child's age and body weight. The goal is to see if it can improve kidney function when used alongside other treatments.

  • ACEI (Angiotensin-Converting Enzyme Inhibitors)

    are medications that help relax blood vessels and reduce blood pressure. They are commonly used to treat high blood pressure and heart conditions. In this trial, they are used in combination with finerenone to see if they can further help reduce protein in the urine and improve kidney health.

  • ARB (Angiotensin II Receptor Blockers)

    are another type of medication that helps lower blood pressure by blocking the effects of a hormone that causes blood vessels to tighten. Like ACEIs, ARBs are used in this study to see if they can enhance the effects of finerenone in treating children with chronic kidney disease.

What is already known about the treatment

Finerenone – Finerenone is administered orally and is currently being studied in clinical trials for its effectiveness in treating chronic kidney disease and proteinuria in children. It is a mineralocorticoid receptor antagonist, which means it works by blocking the action of certain hormones that can cause kidney damage. This medication is being evaluated for its ability to reduce protein levels in urine, which is a common issue in kidney disease. Finerenone is classified as a diuretic, specifically targeting the mineralocorticoid receptor to help protect kidney function.

Investigated diseases

  • Proteinuria

    Proteinuria is a condition characterized by the presence of excess protein in the urine. It often indicates that the kidneys are not functioning properly, as they are allowing protein to leak into the urine instead of retaining it in the bloodstream. This condition can be a sign of kidney damage or disease. Over time, proteinuria can lead to further kidney damage if the underlying cause is not addressed. It is often detected through routine urine tests. The progression of proteinuria depends on the underlying cause and the effectiveness of managing that cause.

  • Chronic Kidney Disease

    Chronic kidney disease (CKD) is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. This decline in kidney function can occur over months or years and is often caused by conditions like diabetes and high blood pressure. As the disease progresses, waste products can build up in the body, leading to symptoms such as fatigue, swelling, and changes in urination. CKD is typically classified into stages based on the level of kidney function, with each stage indicating a more severe level of damage. The progression of CKD can lead to complications such as anemia, bone disease, and cardiovascular issues.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-504884-17-00Protocol code19920Estimated enrolment506 patientsSponsorBayer AG

sourced from the EU Clinical Trials Register and site verification

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