FIONA

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1004175

• Contact name

  Antonia Vassallo

• Contact email

  antonia.vassallo@bayer.com

• Sponsor organisation

  Bayer AG

• Eudract number

  2021-002071-19

• Clinicaltrials.gov Identifier

  NCT05196035

• Research summary

  A study to learn more about how well the study treatment finerenone works, how safe it is, how it moves into, through, and out of the body, and the effects it has on the body when taken with an ACE inhibitor or angiotensin receptor blocker in children with long-term kidney disease and proteinuria.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  21/NE/0219

• Date of REC Opinion

  11 Jan 2022

• REC opinion

  Further Information Favourable Opinion