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(19920) A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weightadjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children, 6 months to <18 years of age, with chronic kidney disease and proteinuria

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504884-17-00
Acronym
19920
Enrollment
253
Registered
2024-03-18
Start date
2022-02-04
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Proteinuria, Chronic kidney disease

Brief summary

Mean reduction from baseline to Month 6 in Urinary Protein-toCreatinine Ratio (Percent change from baseline to day 180±7 in UPCR)

Detailed description

Number of participants with a. AEs b. Serious TEAEs c. TEAEs and serious TEAEs leading to discontinuation of treatment d. Study drug related TEAEs and serious TEAEs e. TEAEs categorized by severity f. TEAEs by maximum intensity g. No. of participants hospitalized with hyperkalemia h. No. of participants discontinuing due to hyperkalemia i. No. of participants hospitalization for worsening of renal function j. No. of participants discontinuing due to worsening of renal function, Change in serum potassium levels, serum creatinine, eGFR and systolic blood pressure from baseline to day 180±7, Urinary Protein-to-Creatinine Ratio (UPCR) reduction of at least 30% from baseline to day 180±7 (Proportion of responders at the day 180±7 time point, where a responder is defined as a >=30% reduction in UPCR compared to baseline, Change in UACR from baseline to day 180±7, PK (finerenone Cmax,md, AUCτ,md) based on total concentrations in plasma, Taste and texture of the pediatric formulation

Interventions

DRUGPlacebo to Finerenone 10 film-coated tablets
DRUGPlacebo to BAY 948862
DRUGFinerenone
DRUGPlacebo to Finerenone 20 film-coated tablets

Sponsors

Bayer AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Mean reduction from baseline to Month 6 in Urinary Protein-toCreatinine Ratio (Percent change from baseline to day 180±7 in UPCR)

Secondary

MeasureTime frame
Number of participants with a. AEs b. Serious TEAEs c. TEAEs and serious TEAEs leading to discontinuation of treatment d. Study drug related TEAEs and serious TEAEs e. TEAEs categorized by severity f. TEAEs by maximum intensity g. No. of participants hospitalized with hyperkalemia h. No. of participants discontinuing due to hyperkalemia i. No. of participants hospitalization for worsening of renal function j. No. of participants discontinuing due to worsening of renal function, Change in serum potassium levels, serum creatinine, eGFR and systolic blood pressure from baseline to day 180±7, Urinary Protein-to-Creatinine Ratio (UPCR) reduction of at least 30% from baseline to day 180±7 (Proportion of responders at the day 180±7 time point, where a responder is defined as a >=30% reduction in UPCR compared to baseline, Change in UACR from baseline to day 180±7, PK (finerenone Cmax,md, AUCτ,md) based on total concentrations in plasma, Taste and texture of the pediatric formulat

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