100 Participants Needed

Finerenone for Pediatric Chronic Kidney Disease

(FIONA OLE Trial)

Recruiting at 212 trial locations
BC
Overseen ByBayer Clinical Trials Contact
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests finerenone, a new medication added to existing treatments, to help children with chronic kidney disease (CKD) and proteinuria. It aims to see if finerenone can better control kidney function and reduce protein in the urine. The study will monitor safety and effectiveness over several months. Finerenone has been shown to delay the progression of chronic kidney disease.

Will I have to stop taking my current medications?

The trial requires participants to continue taking either an ACEI or ARB at stable doses, but you cannot take certain other medications like mineralocorticoid receptor antagonists or SGLT2 inhibitors. The protocol does not specify a need to stop other medications, but you should discuss your current medications with the study team.

How does the drug Finerenone differ from other treatments for pediatric chronic kidney disease?

Finerenone is unique because it is a non-steroidal mineralocorticoid receptor antagonist, which means it works by blocking certain receptors in the body that can contribute to kidney damage, offering a different mechanism of action compared to traditional treatments like dialysis or transplantation.12345

What data supports the effectiveness of the drug Finerenone for pediatric chronic kidney disease?

Finerenone has been shown to help adults with chronic kidney disease and type 2 diabetes by reducing the risk of kidney function decline and heart-related issues. While this data is for adults, it suggests potential benefits for kidney health that might be relevant for children with chronic kidney disease.678910

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.
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.
See 3 more

Exclusion Criteria

Previous assignment to treatment during this study
I am currently taking specific heart or blood pressure medications.
I have low blood pressure according to my age, sex, and height.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive finerenone in addition to an ACEI or ARB for up to 18 months to assess safety and efficacy in controlling RAAS overactivation

18 months
At least 12 visits for new participants, at least 8 visits for those previously on finerenone

Follow-up

Participants are monitored for safety and effectiveness after treatment, including health checks 30 days post-treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • Finerenone
Trial Overview 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).
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Finerenone Open-Label safety ExtensionExperimental Treatment1 Intervention
Participants will receive finerenone treatment.

Finerenone is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Kerendia for:
  • Chronic kidney disease associated with type 2 diabetes
🇪🇺
Approved in European Union as Kerendia for:
  • Chronic kidney disease associated with type 2 diabetes

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials
2,291
Recruited
25,560,000+
Founded
1863
Headquarters
Leverkusen, Germany
Known For
Pharmaceutical Innovations
Top Products
Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy profile image

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Published Research Related to This Trial

Finerenone is a first-in-class oral medication that selectively targets mineralocorticoid receptors, approved in the USA for reducing the risk of serious complications like kidney decline and heart issues in adults with chronic kidney disease related to type 2 diabetes.
It has shown efficacy in preventing sustained declines in kidney function and reducing cardiovascular risks, and is currently being studied in a phase III trial for heart failure with preserved ejection fraction.
Finerenone: First Approval.Frampton, JE.[2022]
In a study of 13,026 patients with chronic kidney disease (CKD) and type 2 diabetes, finerenone showed similar efficacy in reducing cardiovascular and kidney-related events in Hispanic patients compared to non-Hispanic patients, with a notable 20% reduction in cardiovascular events for those on finerenone.
Finerenone also significantly reduced urinary albumin-to-creatinine ratio (UACR) by 32% at month 4 in both Hispanic and non-Hispanic patients, indicating its effectiveness in improving kidney function, while maintaining a similar safety profile across both groups.
Finerenone in Hispanic Patients With CKD and Type 2 Diabetes: A Post Hoc FIDELITY Analysis.Rosas, SE., Ruilope, LM., Anker, SD., et al.[2023]
Finerenone (Kerendia) is approved for reducing the risk of serious kidney and cardiovascular issues in adults with chronic kidney disease linked to type 2 diabetes.
The medication specifically targets the decline in kidney function and helps prevent complications such as heart failure and heart attacks.
New Type 2 Diabetes Drug AIMS to Reduce Risk of Diminished Kidney Function and Cardiovascular Complications.Aschenbrenner, DS.[2023]

Citations

Finerenone: First Approval. [2022]
Finerenone in Hispanic Patients With CKD and Type 2 Diabetes: A Post Hoc FIDELITY Analysis. [2023]
New Type 2 Diabetes Drug AIMS to Reduce Risk of Diminished Kidney Function and Cardiovascular Complications. [2023]
Finerenone in diabetic kidney disease: A systematic review and critical appraisal. [2022]
Finerenone in Black Patients With Type 2 Diabetes and CKD: A Post hoc Analysis of the Pooled FIDELIO-DKD and FIGARO-DKD Trials. [2023]
Ten-year trends in epidemiology and outcomes of pediatric kidney replacement therapy in Europe: data from the ESPN/ERA-EDTA Registry. [2023]
Renal replacement therapy in children: data from 12 registries in Europe. [2018]
The 1997 Report of the Japanese National Registry data on pediatric peritoneal dialysis patients. [2020]
European chronic kidney disease registries for children not on kidney replacement therapy: tools for improving health systems and patient-centred outcomes. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Medication treatment complexity and adherence in children with CKD. [2021]
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