Clinical Trials List
Protocol Number20186
NCT Number(ClinicalTrials.gov Identfier)NCT05457283
Active
2025-11-01 - 2029-05-31
Phase III
Recruiting5
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
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Trial Applicant
BAYER TAIWAN COMPANY LTD.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/10
Investigators and Locations
Co-Principal Investigator
- Shuenn Nan Chiu Division of Pediatrics
- GWO-TSANN CHUANG Division of Pediatrics
- 黃厚瑄 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yuan-Yow Chiou
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic Kidney Disease
Objectives
The primary objective of the trial is to provide long-term safety data for finerenone in children and young adults with CKD. Other objectives include collecting long-term efficacy data for finerenone and providing continued access to finerenone for all participants previously treated in the FIONA trial.
Test Drug
Tablets
Tablets
Granules for suspension
Granules for suspension
Tablets
Granules for suspension
Granules for suspension
Active Ingredient
Finerenone micronized
BAY 94-8862 granules 3.4% 3 g for oral suspension
BAY 94-8862 granules 3.4% 6 g for oral suspension
BAY 94-8862 granules 3.4% 3 g for oral suspension
BAY 94-8862 granules 3.4% 6 g for oral suspension
Dosage Form
110
110
15C
15C
110
15C
15C
Dosage
10 mg/ tablet
20 mg/ tablet
2.0 mg/mL
20 mg/ tablet
2.0 mg/mL
Endpoints
- Number of subjects who experienced treatment-induced adverse events (TEAEs)
- Changes in serum potassium concentration from baseline to day 540 ± 7 (14th follow-up visit, end of treatment [EoT])
- Changes in systolic blood pressure (SBP) from baseline to day 540 ± 7 (14th follow-up visit, EoT)
- Changes in serum potassium concentration from baseline to day 540 ± 7 (14th follow-up visit, end of treatment [EoT])
- Changes in systolic blood pressure (SBP) from baseline to day 540 ± 7 (14th follow-up visit, EoT)
Inclution 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.
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
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
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
The Estimated Number of Participants
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Taiwan
14 participants
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Global
193 participants
