Finerenone (Kerendia, BAY94-8862) for Children

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Many Locations, Multiple Locations, Israel
Children+4 More
Finerenone (Kerendia, BAY94-8862) - Drug
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

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Children

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

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Children

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: Drug

Trial 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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.