A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weight-adjusted 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

A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weight-adjusted 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 - FIONA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54048

Enrollment

Registered

2021-11-16

Start date

2023-03-28

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

chronic kidney disease chronic kidney disease with proteinuria

Interventions

BAY 94-8862: film-coated tablets 10 mg or 20 mg orally BAY 94-8862 GRAN SUSP 3.4% 3 g ORAL: 2 mg/ml suspension (made from granules, equivalent by body weight) orally or comparable placebo

Eligibility

Age

No minimum to 17 Years

Inclusion criteria

Inclusion criteria: - Participants must be 6 months to

Exclusion criteria

Exclusion criteria: - Planned urological surgery expected to influence renal function - Children with hemolytic uremic syndrome (HUS) diagnosed

Design outcomes

Primary

Measure	Time frame
See section 3 in protocol (V2.0) Number of participants with UPCR reduction of at least 30% from baseline to day 180±7	—

Secondary

Measure	Time frame
See section 3 in protocol (V2.0) Number of participants with adverse events (AEs) Change in serum potassium levels from baseline to day 180±7 Change in serum creatinine from baseline to day 180±7 Change in eGFR from baseline to day 180±7 Change in systolic blood pressure from baseline to day 180±7 Percent change in UPCR from baseline to day 180±7 Change in UACR from baseline to day 180±7 PK based on total concentrations in the plasma Taste and texture of the pediatric formula	—

Measure

Time frame

See section 3 in protocol (V2.0) Number of participants with adverse events (AEs) Change in serum potassium levels from baseline to day 180±7 Change in serum creatinine from baseline to day 180±7 Change in eGFR from baseline to day 180±7 Change in systolic blood pressure from baseline to day 180±7 Percent change in UPCR from baseline to day 180±7 Change in UACR from baseline to day 180±7 PK based on total concentrations in the plasma Taste and texture of the pediatric formula

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)