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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Sep 2024

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At a glance

  • Drugs Finerenone (Primary)
  • Indications Proteinuria; Renal failure
  • Focus Registrational; Therapeutic Use
  • Acronyms FIONA
  • Sponsors Bayer

    • Most Recent Events

    • 12 Mar 2024 According to the trial design published in the Trials, A sample size of 198 participants (aged 2 to <18 years) in FIONA will provide at least 80% power to reject the null hypothesis of either of the two primary endpoints.
    • 12 Mar 2024 Trial design published in the Trials.
    • 08 Feb 2023 Planned End Date changed from 11 Sep 2026 to 11 Mar 2027.

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