Finerenone for Chronic Kidney Disease and Proteinuria in Children and Young Adults
This study is investigating how safe the medication Finerenone (also known as Kerendia or BAY94-8862) is for long-term use in children and young adults (ages 1 to 18) who have chronic kidney disease (CKD) and proteinuria. Proteinuria is a condition where kidneys leak protein into the urine. Participants will take Finerenone along with their existing ACE inhibitor or angiotensin receptor blocker for about 18 months. Researchers will monitor side effects, changes in potassium levels, and changes in blood pressure to understand the drug's safety. This study is for individuals who previously participated in the FIONA study and were not permanently removed from treatment.
- Study design
- This interventional study plans to enroll 100 participants aged 1 to 18 years. The study is investigating the safety of Finerenone in different doses.
- What's involved
- Participants will take Finerenone for approximately 540 days (about 18 months). Safety will be measured up to 550 days, and potassium and blood pressure changes will be measured up to 547 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety up to 550 days after starting treatment, and for changes in potassium and blood pressure up to 547 days.
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NCT05457283
A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria
Recruiting
PHASE3Ages 1–18InterventionalTreatmentBayer
~100 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Finerenone (Kerendia, BAY94-8862)
At a glance
Recruiting sites
34 of 133 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment emergent adverse event (TEAEs)
Measured over Up to 550 days
+2 more outcomes measured
Conditions
Where it's being run
133 sites across 84 statesTurkey (Türkiye)8
Italy6
Greece5
Israel5
Spain5
Argentina4
Poland4
Brazil3
Who to contact
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Eligibility criteria
Inclusion
Participants must be ≥1 year to 18 years of age, at the time of signing the informed consent/assent.
Prior participation in the finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA.
Participants must have a clinical diagnosis of chronic kidney disease (CKD) at Visit 1 which is defined as
CKD stages 1-3 (estimated glomerular filtration rate \[eGFR\] ≥30 mL/min/1.73m\^2) for children ≥1 year to \<19 years of age at FIONA EoT and at Visit 1
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 (BP) management, unchanged for at least 30 days prior to Visit 1.
K+ ≤5.0 mmol/L for children ≥2 years of age at both FIONA EoT and Visit 1, and ≤5.3 mmol/L for children \<2 years of age at both FIONA EoT and Visit 1
Participants who have reached legal age of consent: Capable of giving signed informed consent.
Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding.
Exclusion
Planned urological surgery expected to influence renal function
Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
Systemic hypertension Stage 2 defined according to institutional guidelines on BP management at Visit 1.
Systemic hypotension defined as symptomatic hypotension or a mean systolic BP below the 5th percentile for age, sex and height but no lower than 80 mmHg for participants \<18 years and symptomatic hypotension or a mean systolic blood pressure (SBP) \<90 mmHg in participants ≥18 years at Visit 1.
Known hypersensitivity to the study treatment (active substance or excipients)
Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores.
Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids
Concomitant therapy with a mineralocorticoid receptor antagonist (MRA)(eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any sodium-glucose co-transporter-2 (SGLT2) inhibitor (SGLT2i), sacubitril/valsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene)
Concomitant therapy with both ACEI and ARBs together
Concomitant therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, moderate or strong CYP3A4 inducers
Previous assignment to treatment during this study
Simultaneous participation in another interventional clinical study (e.g., Phase 1 to 4 clinical studies).
Any suspected (serious) adverse event related to study intervention which led to permanent discontinuation during the FIONA study.
Pregnant or breastfeeding or intention to become pregnant during the study
What this trial measures
- Number of participants with treatment emergent adverse event (TEAEs)Up to 550 days
- Change in serum potassium levels from baseline to Day 540±7Up to 547 days
- Change in systolic blood pressure (SBP) from baseline to Day 540±7Up to 547 days