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Finerenone for Chronic Kidney Disease (FIONA Trial)
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.
FIONA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFIONA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FIONA Trial Design
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Who is running the clinical trial?
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- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
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."
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."
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."
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"
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."
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