Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Finerenone (Kerendia, BAY94-8862): Finerenone 10 mg or 20 mg, Once daily, orally for 540 days.
Control Intervention1: NOT APPLICABLE: NOT APPLICABLE
Sponsors
Bayer Pharmaceuticals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants must be greater than or equal to 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. 4. 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. 5. K+ less than or equal to 5.0 mmol/L for children greater than or equal to 2 years of age at both FIONA EoT and Visit 1, and less than or equal to 5.3 mmol/L for children less then 2 years of age at both FIONA EoT and Visit 1. 6. 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: 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 at Visit 1. 4. Systemic hypotension at Visit 1. 5. Known hypersensitivity to the study treatment (active substance or excipients). 6. Severe hepatic insufficiency. 7. Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids. 8. 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). 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. Experienced a drug-related serious adverse event (SAE) or an adverse event (AE) which led to permanent discontinuation of study intervention during the FIONA study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum potassium levels from baseline to Day 540 plus or minus 7 days Change in systolic blood pressure from baseline to Day 540 plus or minus 7 days Number of participants with TEAEsTimepoint: Change in serum potassium levels from baseline to Day 540 plus or minus 7 days Change in systolic blood pressure from baseline to Day 540 plus or minus 7 days Number of participants with TEAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Urinary Protein-to-Creatinine Ratio (UPCR) and Urinary Albumin-to-Creatinine Ratio (UACR) from baseline to Day 540 plus or minus 7 days.Timepoint: From baseline to Day 540 plus or minus 7 days.;Change in estimated Glomerular Filtration Rate (eGFR) from baseline to Day 540 plus or minus 7 days.Timepoint: From baseline to Day 540 plus or minus 7 days | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Republic of Korea, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States of America
Contacts
Public ContactSudiksha Phadnis
Bayer Pharmaceuticals Private Limited
Outcome results
None listed