Finerenone for Pediatric Chronic Kidney Disease

(FIONA OLE Trial)

Recruiting at 257 trial locations

Overseen By Bayer Clinical Trials Contact

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Bayer

Must be taking: ACEI, ARB

Must not be taking: MRAs, Renin inhibitors

Disqualifiers: Planned urological surgery, Renal transplantation, Hypertension, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 18 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called finerenone (also known as Kerendia or BAY 94-8862) to determine its effectiveness for children with chronic kidney disease (CKD) and proteinuria, a condition where excessive protein leaks into the urine. Researchers aim to discover if adding finerenone to standard treatments can improve kidney function and manage protein levels in urine more effectively. Participants should have previously joined the FIONA study and have CKD treated with either an ACE inhibitor (a drug that helps relax blood vessels) or an ARB (a medication that blocks specific hormone actions). The goal is to assess the long-term safety and effectiveness of finerenone for these young patients. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that finerenone is likely to be safe for children with chronic kidney disease?

Research has shown that finerenone is generally easy for people to tolerate. In earlier studies, patients taking finerenone were less likely to develop high potassium levels in their blood compared to those taking similar drugs. Maintaining normal potassium levels is crucial for heart and kidney health.

Additionally, finerenone significantly benefits the kidneys and heart in people with chronic kidney disease. These studies did not find an increase in serious kidney problems with finerenone use. However, monitoring for any side effects during treatment remains important.

Overall, evidence suggests that finerenone is a safe option when used with standard treatments for chronic kidney disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic kidney disease?

Researchers are excited about finerenone for treating pediatric chronic kidney disease because it offers a novel approach compared to traditional treatments like ACE inhibitors or ARBs. Unlike these standard treatments, which primarily focus on controlling blood pressure, finerenone works by blocking mineralocorticoid receptors, which play a significant role in kidney inflammation and fibrosis. This new mechanism of action has the potential to more directly address the underlying causes of kidney damage, offering hope for improved outcomes in young patients.

What evidence suggests that finerenone might be an effective treatment for chronic kidney disease in children?

Research has shown that finerenone, when combined with standard treatments like ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB), can significantly improve kidney health in people with chronic kidney disease (CKD). Studies have found that finerenone lowers the risk of kidney failure and slows the decline in kidney function. It also reduces protein leakage into the urine, a major issue in CKD. By controlling the overactivity of the renin-angiotensin-aldosterone system (RAAS), finerenone helps maintain better kidney function. This makes it a promising treatment for managing CKD in children. Participants in this trial will receive finerenone to evaluate its safety and effectiveness in pediatric CKD. ^{1 4 5 6 7}

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.

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.

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?

Group I: Finerenone Open-Label safety Extension Experimental Treatment 1 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

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

Bayer

Chief Medical Officer since 2014

MD, PhD

Published Research Related to This Trial

In a study of 558 children with chronic kidney disease (CKD), it was found that the number of medications prescribed for comorbidities increased significantly with more advanced CKD stages and specific kidney disease types, indicating a complex treatment landscape.

Nonadherence to medication was linked to the frequency of dosing rather than the total number of medications, suggesting that simplifying treatment regimens could help improve adherence in pediatric CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication treatment complexity and adherence in children with CKD. Blydt-Hansen, TD., Pierce, CB., Cai, Y., et al.[2021]

In a study of 807 pediatric patients under 16 years old on chronic peritoneal dialysis (PD), the survival rates were high, with 91% surviving after 3 years and 86% after 5 years, indicating the efficacy of PD as a treatment option.

However, younger children (under 6 years) had poorer outcomes, highlighting the need for careful management in this age group, as they experienced higher rates of complications and lower survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 1997 Report of the Japanese National Registry data on pediatric peritoneal dialysis patients. Honda, M.[2020]

In a study of 13,026 patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), finerenone showed similar efficacy in reducing cardiovascular and kidney-related complications in both Black (4.0% of participants) and non-Black patients, indicating its effectiveness across diverse populations.

Finerenone significantly reduced the urine albumin-to-creatinine ratio by 40% in Black patients and slowed chronic eGFR decline, demonstrating its potential to protect kidney function and cardiovascular health in patients with CKD and T2D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finerenone in Black Patients With Type 2 Diabetes and CKD: A Post hoc Analysis of the Pooled FIDELIO-DKD and FIGARO-DKD Trials. Flack, JM., Agarwal, R., Anker, SD., et al.[2023]

The prevalence of renal replacement therapy (RRT) in children has significantly increased from 22.9 per million in 1980 to 62.1 per million in 2000, while the incidence has stabilized at around 9.9 per million since 1985.

Patient survival rates have improved, with a 36% reduction in the risk of death for dialysis patients and a 42% reduction for transplant recipients starting treatment between 1995 and 2000 compared to those starting between 1980 and 1984.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal replacement therapy in children: data from 12 registries in Europe. van der Heijden, BJ., van Dijk, PC., Verrier-Jones, K., et al.[2018]

The ESPN/ERA Registry has been collecting valuable data on children with chronic kidney disease (CKD) undergoing kidney replacement therapy since 2007, highlighting the need for ongoing research in this challenging area.

A recent survey identified eight existing CKD registries across 38 European countries, suggesting a promising opportunity to link these registries to better monitor disease progression and improve patient outcomes in children with CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European chronic kidney disease registries for children not on kidney replacement therapy: tools for improving health systems and patient-centred outcomes. Bakkaloğlu, SA., Vidal, E., Bonthuis, M., et al.[2023]

Finerenone, a new non-steroidal mineralocorticoid antagonist, shows better renal outcomes compared to spironolactone and improved mortality outcomes compared to eplerenone in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), with fewer instances of hyperkalemia.

In long-term studies, finerenone significantly reduces the progression of renal disease and cardiovascular events, particularly heart failure hospitalizations, without affecting HbA1c, body weight, or causing sexual side effects, although it does have a higher rate of hyperkalemia leading to drug withdrawal compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finerenone in diabetic kidney disease: A systematic review and critical appraisal. Singh, AK., Singh, A., Singh, R., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finerenone in Hispanic Patients With CKD and Type 2 Diabetes: A Post Hoc FIDELITY Analysis. Rosas, SE., Ruilope, LM., Anker, SD., et al.[2023]

The incidence of children under 15 starting kidney replacement therapy (KRT) in Europe remained stable from 2007 to 2016, ranging between 5.5 and 6.6 per million age-related population, indicating consistent rates of new cases.

The prevalence of KRT among children increased by 2% annually, with a notable rise in kidney transplantation and peritoneal dialysis, while five-year patient survival rates remained high at around 94%, showing effective long-term outcomes for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten-year trends in epidemiology and outcomes of pediatric kidney replacement therapy in Europe: data from the ESPN/ERA-EDTA Registry. Bonthuis, M., Vidal, E., Bjerre, A., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Type 2 Diabetes Drug AIMS to Reduce Risk of Diminished Kidney Function and Cardiovascular Complications. Aschenbrenner, DS.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05196035

NCT05196035 | A Study to Learn More About How Well the ... Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies. Trials ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10956186/

Investigating the use of finerenone in children with chronic ... Similarly, finerenone reduced the risk of the composite kidney outcome (kidney failure, a sustained ≥ 57% decrease in estimated glomerular ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02540993

NCT02540993 | Efficacy and Safety of Finerenone in ... The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression ...

4. apm.amegroups.org apm.amegroups.org/article/view/74326/html

Efficacy and safety of finerenone in patients with chronic ... One trial (26) included in this meta-analysis reported that the incidence of kidney failure was significantly lower in the finerenone group than in the placebo ...

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2021/215341Orig1s000IntegratedR.pdf

215341Orig1s000 - accessdata.fda.gov chronic kidney disease (CKD) and type 2 diabetes (T2D). Finerenone does not lower arterial blood pressure at doses that slow the progression ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10664185/

Pharmacotherapy considerations with finerenone in the ... Finerenone has a reduced risk of hyperkalemia compared to steroidal MRAs, which can be safely managed for most patients with appropriate monitoring and ...

7. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.819327/full

Efficacy and Safety of Finerenone in Chronic Kidney Disease Conclusion: Data from our meta-analysis suggest that finerenone confers significant renal and cardiovascular benefits in patients with CKD.