Abstract: INFO09-FR
Finerenone for the Treatment of Children with CKD and Proteinuria (FIONA)
Session Information
- Informational Posters - 2
November 07, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- No subcategory defined
Author
- Mukhopadhyay, Pinaki, Nilratan Sircar Medical College, Kolkata, WB, India
Description
A 6-month multicentre, 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. (FIONA). (CTRI/2025/04/084877)
Primary Sponsor: Bayer Pharmaceuticals Private Limited. Study Place: Nil Ratan Sircar Medical College and Hospital, Kolkata, India. Inclusion criteria: Participants must be 6 months to less than 18 years old at the time when the informed consent/assent is signed. Participants must have a clinical diagnosis of chronic kidney disease CKD at screening Participants must have stable kidney function Treated 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 screening. Primary end point: Urinary protein to creatinine ratio reduction of at least 30% from baseline to day 180 plus or minus 7 days. Secondary Outcome: Change in serum potassium levels from base line to day 180 Plus or Minus Seven days. Change in eGFR from baseline to day 180 Plus or Minus 7 days. Intervention: Finerenone 10 mg or 20 mg, Once daily, orally for 180 days
Researchers are looking for a better way to treat children who have chronic kidney disease (CKD),which is long-term kidney disease, and proteinuria. The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB.
The main purpose of this study is to learn more about whether finerenone added to either ACEI or ARB can help reduce the amount of protein in the participants’ urine more than a placebo. Participants will also continue to receive their other medications. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Date of First Enrolment (India) 30/04/2025. Date of Study Completion(India): Applicable only for Completed/Terminated trials. Recruitment Status of Trial(Global) Open to Recruitment . Estimated Duration of Trial : 2 Years.
Funding
- Bayer Pharmaceuticals Private Limited