Finerenone (Kerendia, BAY94-8862) for Children
Phase-Based Progress Estimates
Effectiveness
Safety
Many Locations, Multiple Locations, Israel
Children+4 More
Finerenone (Kerendia, BAY94-8862) - DrugEligibility
< 65
All Sexes
What conditions do you have?
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Eligibility
< 65
All Sexes
What conditions do you have?
Select
Study 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. Finerenone (Kerendia, BAY94-8862) is a drug that is used to treat children. This drug has previously been approved by the FDA for a different condition. However, in this particular trial, there will be no patients receiving a placebo.
Eligible Conditions
- Children
- Chronic Kidney Disease (CKD)
- Proteinuria
Treatment Effectiveness
Study Objectives
3 Primary · 3 Secondary · Reporting Duration: Up to 550 days
Up to 547 days
Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7
Change in serum potassium levels from baseline to Day 540±7
Change in systolic blood pressure (SBP) 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
Up to 550 days
Number of participants with treatment emergent adverse event (TEAEs)
Trial Safety
Trial Design
1 Treatment Group
Finerenone Open-Label safety Extension
1 of 1
Experimental Treatment
100 Total Participants · 1 Treatment Group
Primary Treatment: Finerenone (Kerendia, BAY94-8862) · No Placebo Group · Phase 3
Finerenone Open-Label safety Extension
Drug
Experimental Group · 1 Intervention: Finerenone (Kerendia, BAY94-8862) · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 550 days
Closest Location: Many Locations · Multiple Locations, Canada
2018First Recorded Clinical Trial
2 TrialsResearching Children
36 CompletedClinical Trials
Who is running the clinical trial?
BayerLead Sponsor
2,132 Previous Clinical Trials
23,823,596 Total Patients Enrolled
2 Trials studying Children
68 Patients Enrolled for Children
Eligibility Criteria
Age < 65 · All Participants · 7 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have participated in the FIONA study and are not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA.
You are at least 1 year to 18 years of age.
You have a serum potassium level of at least 5.0 mmol/L at both FIONA EoT and Visit 1.
You are ≥1 year of age and have a eGFR ≥30 mL/min/1.73m^2 at FIONA EoT and at Visit 1.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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