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 in Children With Chronic Kidney Disease and Proteinuria.

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 - FIONA

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084877

Enrollment

219

Registered

2025-04-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified

Interventions

Intervention1: Finerenone (Kerendia, BAY94-8862): Finerenone 10 mg or 20 mg, Once daily, orally for 180 days. Control Intervention1: Drug: Placebo: Placebo to finerenone, 10 mg or 20 mg, Once daily

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Urinary protein to creatinine ratio reduction of at least THIRTY PERCENT from baseline to day 180 plus or minus 7 daysTimepoint: Urinary protein to creatinine ratio reduction of at least THIRTY PERCENT from baseline to day 180 plus or minus 7 days	—

Secondary

Measure	Time frame
Number participants with treatment emergent adverse eventsTimepoint: From the start of study intervention (Baseline) to last study intervention plus THREE days up to 190 days;Change in serum potassium levels from baseline to day 180 Plus or Minus Seven daysTimepoint: From baseline to day 180 Plus or Minus Seven days;Change in eGFR from baseline to day 180 Plus or Minus 7 daysTimepoint: From baseline to day 180 Plus or Minus 7 days	—

Measure

Time frame

Number participants with treatment emergent adverse eventsTimepoint: From the start of study intervention (Baseline) to last study intervention plus THREE days up to 190 days;Change in serum potassium levels from baseline to day 180 Plus or Minus Seven daysTimepoint: From baseline to day 180 Plus or Minus Seven days;Change in eGFR from baseline to day 180 Plus or Minus 7 daysTimepoint: From baseline to day 180 Plus or Minus 7 days

—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Republic of Korea, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United States of America

Contacts

Public ContactAnand Pendse

Manager Clinical Operations

anand.pendse@bayer.com919820563905

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026