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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: 31 Dec 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

    • 08 Nov 2024 Planned End Date changed from 11 Mar 2027 to 31 Aug 2027.
    • 08 Nov 2024 Planned primary completion date changed from 11 Feb 2027 to 31 Jul 2027.
    • 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.

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