Research Project

Project Title:	18-month, open-label, single-arm safety extension study of an age and bodyweightadjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children and young adults (1 to 18 years) with chronic kidney disease and proteinuria
Project Type:	Clinical Trial, Enrolment ongoing Adjunct biobank: DNA, Serum, Plasma, Urine
Disease group(s):	Hereditary glomerulopathies, Immune glomerulopathies, Congenital malformations & ciliopathies, Pediatric kidney transplantation
Project Summary:	The study will be an 18-month, multicenter, single-arm, open-label study to evaluate the longterm safety and efficacy of an age- and bodyweight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of pediatric and young adult patients, 1 to <19 years of age, with CKD stages 1-3 (eGFR ≥30 mL/min/1.73 m2). Only patients who completed the double-blind FIONA study (Study 19920) will qualify for inclusion in the FIONA OLE study.
Lead principal investigator(s):	Enrico Verrina, Genoa
Co-investigator(s):	Francesca Lugani, Genoa Ida Maria Schmidt, Copenhagen
Project Period:	01/2023 - 01/2028
Sponsors:	Industry
Project web page:	http://www.bayer.dk