Skip to content

(20186 - FIONA OLE) 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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504885-50-00
Acronym
20186
Enrollment
69
Registered
2024-03-27
Start date
2022-11-07
Completion date
Unknown
Last updated
2025-11-25

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

Brief summary

Number of participants with treatment emergent adverse events (TEAEs), Change in serum potassium levels from baseline to Day 540±7, Change in systolic blood pressure (SBP) from baseline to Day 540±7

Detailed description

Change in urinary protein-to-creatinine ratio (UPCR) and urinary albumin-to-creatinine ratio (UACR) from baseline to Day 540±7, Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7

Interventions

DRUGFinerenone

Sponsors

Bayer AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Number of participants with treatment emergent adverse events (TEAEs), Change in serum potassium levels from baseline to Day 540±7, Change in systolic blood pressure (SBP) from baseline to Day 540±7

Secondary

MeasureTime frame
Change in urinary protein-to-creatinine ratio (UPCR) and urinary albumin-to-creatinine ratio (UACR) from baseline to Day 540±7, Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026