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Mineralocorticoid Receptor Antagonist

Finerenone for Chronic Kidney Disease (FIONA Trial)

Phase 3
Recruiting
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening
Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on day 30±3 and day 180±7
Awards & highlights

FIONA Trial Summary

This trial will help researchers learn if finerenone added to either an ACEI or ARB can help reduce the amount of protein in the participants' urine more than a placebo.

Who is the study for?
This trial is for children aged 6 months to under 18 years with chronic kidney disease and proteinuria, who are already taking optimized doses of ACE inhibitors or ARB medications. They must have stable kidney function and normal potassium levels. Children with recent severe kidney issues, certain blood pressure conditions, planned surgeries affecting kidneys, or those on specific immune treatments are excluded.Check my eligibility
What is being tested?
The study tests if finerenone added to standard treatment (ACE inhibitor or ARB) better reduces urine protein in kids with chronic kidney disease than a placebo. It involves monitoring the drug's effects through regular health checks including blood and urine tests over approximately six months.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of finerenone may include high potassium levels, low blood pressure, dizziness, changes in heart rhythm or rate; as it affects RAAS which controls these functions.

FIONA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with chronic kidney disease.
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I am between 6 months and 18 years old.
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My kidney function has been stable recently.
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I am taking the highest dose of ACEI or ARB medication.

FIONA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on day 30±3 and day 180±7
This trial's timeline: 3 weeks for screening, Varies for treatment, and on day 30±3 and day 180±7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urinary protein-to-creatinine ratio (UPCR) reduction of at least 30% from baseline to day 180±7
Secondary outcome measures
Change in UACR from baseline to day 180±7
Change in eGFR from baseline to day 180±7
Change in serum creatinine from baseline to day 180±7
+7 more

FIONA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Finerenone (Kerendia, BAY94-8862)Experimental Treatment1 Intervention
Participants will receive finerenone treatment.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo to finerenone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Finerenone (Kerendia, BAY94-8862)
2021
Completed Phase 2
~18800

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,233 Previous Clinical Trials
25,326,101 Total Patients Enrolled

Media Library

Chronic Kidney Disease Clinical Trial 2023: Finerenone Highlights & Side Effects. Trial Name: NCT05196035 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the participants in this research over the age of 25?

"As specified in the eligibility requirements, potential participants for this study must aged between 6 months and 17 years old."

Answered by AI

What is the limit to how many patients can be in this trial?

"A total of 219 patients are required for this trial, and these patients must meet the specific inclusion criteria. The trial is taking place in Boston hildren's Hospital in Boston, Quebec and CHU Sainte-Justine in Montreal, Missouri."

Answered by AI

If this clinical trial were to take place in an urban area, would there be many locations available?

"There are a total of 12 clinical trial sites for this study, which are located in Boston, Montreal, Kansas City, and 12 other cities. It would be best to choose the location nearest you to limit travel."

Answered by AI

Could I take part in this experiment if I meet the requirements?

"This clinical trial is open to 219 people between the ages of 6 months and 17 who have proteinuria. In order to be eligible, patients must also meet the following criteria: Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed, CKD 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, severely increased proteinuria as defined by, Urinary"

Answered by AI

What are the risks associated with taking Finerenone (Kerendia, BAY94-8862)?

"Finerenone (Kerendia, BAY94-8862) has received a score of 3 for safety. This is due to being a Phase 3 trial, which has data supporting both efficacy and safety from multiple rounds of testing."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/Ob
What portion of applicants met pre-screening criteria?
Did not meet criteria
~128 spots leftby Feb 2027