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Long-term safety of Finerenone for children with chronic kidney disease

An 18-month, Open-label, Single-arm Safety Extension Study of an age-and Bodyweight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria

Phase 3 Interventional Bayer · NCT05457283

This study is testing the long-term safety of a medication called Finerenone in children and young adults with chronic kidney disease to see how it works when used with other common treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment100 (estimated)
Ages1 Year to 18 Years
SexAll
SponsorBayer Industry-sponsored
Drugs / interventionsrituximab, cyclophosphamide
Locations178 sites (Phoenix, Arizona and 177 other locations)
Trial IDNCT05457283 on ClinicalTrials.gov

What this trial studies

This study investigates the long-term safety of Finerenone, a medication, when used alongside ACE inhibitors or angiotensin receptor blockers in children and young adults aged 1 to 18 years with chronic kidney disease (CKD) and proteinuria. The research aims to improve treatment outcomes for these patients by monitoring the effects of Finerenone over an 18-month period. Participants must have previously taken part in a related Phase 3 study and meet specific health criteria. The study focuses on managing CKD and associated hypertension through optimized medication regimens.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 1 to 18 years with a clinical diagnosis of chronic kidney disease and who have been treated with ACE inhibitors or angiotensin receptor blockers.

Not a fit: Patients who do not have chronic kidney disease or are not currently on ACE inhibitors or angiotensin receptor blockers may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for children suffering from chronic kidney disease and proteinuria.

How similar studies have performed: Other studies have shown promise in using similar approaches for managing chronic kidney disease in children, but this specific combination of treatments is being explored for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Phoenix, Arizona and 177 other locations

+128 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Kidney DiseaseProteinuriaChildren
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.