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Mineralocorticoid Receptor Antagonist
Finerenone for Pediatric Chronic Kidney Disease (FIONA OLE 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 be ≥1 year to 18 years of age, at the time of signing the informed consent/assent
Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 550 days
Awards & highlights
FIONA OLE Trial Summary
This trial is studying a drug called finerenone to see if it is safe and effective to treat children with chronic kidney disease and proteinuria.
Who is the study for?
This trial is for children and young adults aged 1 to 18 with chronic kidney disease (CKD) and proteinuria. They must have been part of the FIONA study, not planning a kidney transplant soon, not have severe high blood pressure or liver issues, and be on stable doses of ACE inhibitors or ARBs. Kids under 2 should have potassium levels ≤5.3 mmol/L; older kids ≤5.0 mmol/L.Check my eligibility
What is being tested?
The trial tests the safety of finerenone when taken alongside an ACE inhibitor or ARB over 18 months in managing CKD and proteinuria in children. It will monitor adverse events, potassium levels, blood pressure, urine protein levels (UACR & UPCR), serum creatinine, and estimated glomerular filtration rate (eGFR).See study design
What are the potential side effects?
Possible side effects include changes in electrolyte levels like potassium which can affect heart rhythm, low blood pressure symptoms if they occur, allergic reactions to medication components, as well as other potential treatment-related medical problems.
FIONA OLE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 1 and 18 years old.
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I can eat solid food or receive nutrition through a feeding tube.
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I am of legal age and can sign my own consent.
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I have been on a stable dose of ACEI or ARB for blood pressure for at least 30 days.
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I have been diagnosed with early-stage chronic kidney disease.
FIONA OLE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 550 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 550 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in serum potassium levels from baseline to Day 540±7
Change in systolic blood pressure (SBP) from baseline to Day 540±7
Number of participants with treatment emergent adverse event (TEAEs)
Secondary outcome measures
Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7
Change in urinary albumin-to-creatinine ratio (UACR) from baseline to Day 540±7
Change in urinary protein-to-creatinine ratio (UPCR) from baseline to Day 540±7
FIONA OLE Trial Design
1Treatment groups
Experimental Treatment
Group I: Finerenone Open-Label safety ExtensionExperimental Treatment1 Intervention
Participants will receive finerenone treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Finerenone
FDA approved
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,240 Previous Clinical Trials
25,332,677 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking specific heart or blood pressure medications.I have low blood pressure according to my age, sex, and height.I am between 1 and 18 years old.You have previously taken part in the finerenone Phase 3 study FIONA (19920) and did not stop the treatment permanently by the end of the study.I can eat solid food or receive nutrition through a feeding tube.My liver is not working well (severe issues).I am not taking strong medications that affect liver enzymes.I am scheduled for a kidney transplant during the study.Children aged 2 years and older should have potassium levels no higher than 5.0 mmol/L, and children under 2 years of age should have potassium levels no higher than 5.3 mmol/L at specific times.I stopped a study treatment permanently due to a serious side effect in the FIONA study.I have been on a stable dose of ACEI or ARB for blood pressure for at least 30 days.I am of legal age and can sign my own consent.I am currently using medications like rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids.My blood pressure is very high according to my doctor's guidelines.I am scheduled for a surgery that may affect my kidney function.I am taking both ACE inhibitors and ARBs medications together.I have been diagnosed with early-stage chronic kidney disease.
Research Study Groups:
This trial has the following groups:- Group 1: Finerenone Open-Label safety Extension
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people with the study's specified medical condition able to enroll at this time?
"As of now, this clinical trial is not recruiting patients. The study was posted on November 2nd, 2022 and last updated on October 12th, 2022. However, 563 other trials are actively looking for participants."
Answered by AI
How can I sign up for this clinical trial?
"This clinical trial is looking for 100 participants with children aged 1-18 years old. Some of the eligibility requirements include: Prior participation in the finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA, being 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 (BP) management, unchanged for at least 30 days prior to Visit 1"
Answered by AI
What have been the most severe reactions to Finerenone (Kerendia, BAY94-8862)?
"Finerenone (Kerendia, BAY94-8862) is a Phase 3 trial medication, meaning that it has undergone multiple rounds of clinical testing and there is some data supporting its efficacy. Our team at Power rates its safety as a 3."
Answered by AI
Does this research exclude people below a certain age?
"Participants in this trial must be aged 1 to 18 years old. Out of 571 total trials, this study is one of 86 that specifically focuses on minors and one 485 studies targeting people over the age of 65."
Answered by AI
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