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

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 - FIONA OLE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002905-89-BE

Enrollment

100

Registered

2022-08-05

Start date

2022-11-22

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of children with chronic kidney disease and proteinuria MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.1 Level: PT Classification code 10037032 Term: Proteinuria System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: Finerenone Product Code: BAY 94-8862 10 mg Pharmaceutical Form: Coated tablet INN or Proposed INN: Finerenone CAS Number: 1050477-31-0 Current Sponsor code: BAY 94-8862 Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants must be =1 year to 18 years of age, at the time of signing the informed consent/assent. 2. 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. 3. 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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Planned urological surgery expected to influence renal function 2. Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame 3. Systemic hypertension Stage 2 defined according to institutional guidelines on BP management at Visit 1. 4. 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. 5. Known hypersensitivity to the study treatment (active substance or excipients) 6. Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores. 7. Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or prolonged high-dose glucocorticoids (defined as = 0.5 mg/kg/day of prednisolone or equivalent) for more than 7 days 8. Concomitant therapy with a mineralocorticoid receptor antagonist (MRA) (eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any sodium-glucose cotransporter-2 (SGLT2) inhibitor (SGLT2i), sacubitril/valsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene) 9. Concomitant therapy with both ACEI and ARBs together 10. Concomitant therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, moderate or strong CYP3A4 inducers 11. Previous assignment to treatment during this study 12. Simultaneous participation in another interventional clinical study (e.g., Phase 1 to 4 clinical studies). 13. Any suspected (S)AE related to the study intervention which led to permanent discontinuation of study intervention during the FIONA study 14. Pregnant or breastfeeding or intention to become pregnant during the study

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to demonstrate that finerenone in addition to an ACEI or ARB is safe when given long-term.;Secondary Objective: The secondary objective is to assess the long-term treatment effects on proteinuria and kidney function of finerenone in addition to standard of care.;Primary end point(s): 1. Number of participants with treatment emergent adverse events (TEAEs) 2. Change in serum potassium levels from baseline to Day 540±7 3. Change in systolic blood pressure (SBP) from baseline to Day 540±7;Timepoint(s) of evaluation of this end point: Up to 547 days	—

Measure

Time frame

Main Objective: The main objective is to demonstrate that finerenone in addition to an ACEI or ARB is safe when given long-term.;Secondary Objective: The secondary objective is to assess the long-term treatment effects on proteinuria and kidney function of finerenone in addition to standard of care.;Primary end point(s): 1. Number of participants with treatment emergent adverse events (TEAEs) 2. Change in serum potassium levels from baseline to Day 540±7 3. Change in systolic blood pressure (SBP) from baseline to Day 540±7;Timepoint(s) of evaluation of this end point: Up to 547 days

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Change in urinary protein-to-creatinine ratio (UPCR) and urinary albumin-to-creatinine ratio (UACR) from baseline to Day 540±7 2. Change in glomerular filtration rate (eGFR) from baseline to Day 540±7;Timepoint(s) of evaluation of this end point: Up to 547 days	—

Countries

Argentina, Australia, Austria, Belgium, Canada, Czechia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Lithuania, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer AG

clinical-trials-contact@bayer.com0049303001139003

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026