Last updated 43 days ago
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 Chronic Kidney Disease and Proteinuria
219 patients around the world
Available in Argentina, United States, Spain
Bayer
7Research sites
219Patients around the world
This study is for people with
Renal disease
Chronic kidney disease
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- Participants must be 6 months to <18 years old at the time when the informed consent/assent is signedParticipants must have a clinical diagnosis of chronic kidney disease (CKD) at screening which is defined asCKD stages 1-3 (eGFR ≥30 mL/min/1.73m^2) for children ≥1 year to <18 years of age or a serum creatinine ≤ 0.40 mg/dL for infants 6 months to < 1 year of age and severely increased proteinuria as defined byUrinary protein-to-creatinine ratio (UPCR) of ≥ 0.50 g/g in participants ≥ 2 years with CKD stage 2 and 3 or UPCR ≥ 1.0 g/g for patients < 2 years of age or ≥ 2 years of age and with CKD stage 1Participants must have stable kidney function between screening and D0 defined as: no increase or decrease in eGFR ≥ 15% for children ≥1 year or no increase or decrease in creatinine ≥ 0.10 mg/dL for children <1 yearTreated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure management, unchanged for at least 30 days prior to screeningK+ ≤5.0 mmol/L for children ≥2 years of age at both screening and D0, and ≤5.3 mmol/L for children <2 years of age at both screening and D0
- Planned urological surgery expected to influence renal functionChildren with hemolytic uremic syndrome (HUS) diagnosed ≤6 months prior to screeningPatients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screeningPatients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frameRenal allograft in placeBilateral renal artery stenosisAcute kidney injury requiring dialysis within 6 months prior to screeningSystemic hypertension stage 2 in children ≥1 year of age defined according to guidelines on blood pressure management at screening or randomizationSystolic blood pressure (SBP) above 110 mmHg in infants 6 months to <1 year of age at screening or randomizationSystemic hypotension defined as a systolic blood pressure below the 5th percentile for age, sex and height at either screening or randomization but no lower than 80 mmHg (although for some participants the 5th percentile of SBP is < 80 mmHg they must be excluded if their SBP is <80 mmHg)Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or high-dose glucocorticoids, within <6 months prior to screening
Sites
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Hospital General de Niños Dr. Ricardo Gutierrez
Hospital Sant Joan de Déu Barcelona
Recruiting
Hospital Vall de Hebrón
Recruiting
Hospital Universitario 12 de Octubre
Recruiting
Hospital Regional Universitario de Málaga
Recruiting
Hospital Uiversitario Virgen del Rocío
Recruiting
StudyFIONA
SponsorBayer
Study typeInterventional
Conditions
Chronic kidney disease
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05196035
