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A Study of Finerenone for Chronic Kidney Disease in Children

This study is investigating finerenone (Kerendia, BAY94-8862) to see how well it works and how safe it is for children aged 6 months to 17 years who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria (when kidneys leak protein into the urine). Researchers also want to understand how finerenone moves through the body and its effects when taken with other common kidney medications. The main goal is to see if finerenone can reduce the amount of protein in the urine. You might receive finerenone or a placebo (an inactive substance) for about 6 months. This study is currently recruiting up to 219 participants.

Study design
This interventional study will involve up to 219 participants who will receive either finerenone or a placebo. The study's phase is not specified.
What's involved
Participants will take finerenone or a placebo for approximately 180 days (about 6 months). The specific number of visits or procedures is not detailed.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at day 180+/-7, which suggests follow-up for at least this duration after starting treatment.

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NCT05196035

A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria

Active, Not Recruiting
PHASE3Ages 6–17InterventionalTreatment
Bayer
~219 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Finerenone (Kerendia, BAY94-8862)Placebo

At a glance

Recruiting sites
0 of 132 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent change in Urinary protein-to-creatinine ratio (UPCR) reduction from baseline to day 180+/-7
Measured over From baseline to day 180+/-7

Conditions

Chronic Kidney Disease
Proteinuria

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Chronic Kidney DiseaseProteinuria

Where it's being run

132 sites across 82 states
Turkey (Türkiye)8
Italy6
Greece5
Israel5
Spain5
Argentina4
Poland4
Taiwan4

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants must be 6 months to \<18 years old at the time when the informed consent/assent is signed
Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening which is defined as
CKD stages 1-3 (eGFR ≥30 mL/min/1.73m\^2) for children ≥1 year to \<18 years of age or
a serum creatinine ≤ 0.40 mg/dL for infants 6 months to \< 1 year of age and
severely increased proteinuria as defined by
Urinary protein-to-creatinine ratio (UPCR) of ≥ 0.50 g/g in participants ≥ 2 years with CKD stage 2 and 3 or
UPCR ≥ 1.0 g/g for patients \< 2 years of age or ≥ 2 years of age and with CKD stage 1
Participants must have stable kidney function between screening and D0 defined as:
For participants with a creatinine of \> 0.8 mg/dL at screening: no increase or decrease in eGFR by ≥ 20% at D0
For participants with a creatinine of ≤ 0.8 mg/dL at screening: no increase or decrease in creatinine ≥ 0.15 mg/dL at D0.
Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure management, unchanged for at least 30 days prior to screening
K+ ≤5.0 mmol/L for children ≥2 years of age at both screening and D0, and ≤5.3 mmol/L for children \<2 years of age at both screening and D0

Exclusion

Planned urological surgery expected to influence renal function
Children with hemolytic uremic syndrome (HUS) diagnosed ≤6 months prior to screening
Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening
Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
Renal allograft in place
Bilateral renal artery stenosis
Acute kidney injury requiring dialysis within 6 months prior to screening
Systemic hypertension stage 2 in children ≥1 year of age defined according to guidelines on blood pressure management at screening or randomization
Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to \<1 year of age at screening or randomization
Systemic hypotension defined as a systolic blood pressure below the 5th percentile for age, sex and height at either screening or randomization but no lower than 80 mmHg (although for some participants the 5th percentile of SBP is \< 80 mmHg they must be excluded if their SBP is \<80 mmHg)
Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or high-dose glucocorticoids, within \<6 months prior to screening

What this trial measures

  • Percent change in Urinary protein-to-creatinine ratio (UPCR) reduction from baseline to day 180+/-7From baseline to day 180+/-7

    Percent change from baseline to day 180±7 in UPCR will be calculated.