Status:
RECRUITING
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
Lead Sponsor:
Bayer
Conditions:
Chronic Kidney Disease
Proteinuria
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief Summary
Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak prote...
Eligibility Criteria
Inclusion Criteria:
-
Participants must be ≥1 year to 18 years of age, at the time of signing the informed consent/assent.
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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.
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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
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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.
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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
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Participants who have reached legal age of consent: Capable of giving signed informed consent.
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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
Key Trial Info
Start Date :
November 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 27 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05457283
Start Date
November 8 2022
End Date
February 27 2029
Last Update
April 14 2026
Active Locations (178)
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1
Phoenix Children's Hospital | Main - Transplant Department
Phoenix, Arizona, United States, 85016
2
Cedars-Sinai Samuel Oschin Cancer Center
Los Angeles, California, United States, 90048
3
Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
Palo Alto, California, United States, 94304
4
Rady Children's Hospital San Diego - Cardiology
San Diego, California, United States, 92123