FIONA OLE

• Research type

  Research Study

• Full title

  An 18-month, open-label, single-arm safety extension study of an age-and bodyweight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuria

• IRAS ID

  1005950

• Contact name

  Antonia Vassallo

• Contact email

  antonia.vassallo@bayer.com

• Eudract number

  2021-002905-89

• Clinicaltrials.gov Identifier

  NCT05457283

• Research summary

  A study to learn more about how safe the study treatment finerenone is in long-term use when taken with an ACE inhibitor or angiotensin receptor blocker over 18 months of use in children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuria.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  22/NE/0116

• Date of REC Opinion

  27 Sep 2022

• REC opinion

  Further Information Favourable Opinion