Finerenone for Chronic Kidney Disease

(FIONA Trial)

Recruiting at 286 trial locations

Overseen By For trial location information (Phone Menu Options '3' or '4')

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Bayer

Must be taking: ACEI, ARB

Must not be taking: Rituximab, Cyclophosphamide

Disqualifiers: Planned urological surgery, Nephrotic syndrome, others

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: 10

Duration: 180 days

219 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding finerenone (Kerendia) to existing medications like ACEI or ARB can better manage chronic kidney disease (CKD) in children. Researchers seek to find out if this combination reduces protein levels in urine more effectively than a placebo. Children with CKD who regularly have protein in their urine and are already on ACEI or ARB treatments might be suitable candidates. Participants will undergo routine check-ups, including blood and urine tests, to monitor their health and the treatment's effects. 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 does not require you to stop taking your current medications. In fact, participants will continue taking either an ACEI or ARB as part of their normal treatment along with the study medication, finerenone or a placebo.

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

A previous study showed that finerenone lowers the risk of worsening kidney disease and heart problems in patients with chronic kidney disease (CKD) and type 2 diabetes. This suggests finerenone benefits kidney and heart health. Another analysis found that patients taking finerenone had better kidney results, as indicated by improvements in certain urine tests.

Regarding safety, research has shown that finerenone is generally well-tolerated. Studies found that patients did not experience serious side effects more often than those taking a placebo, indicating few major side effects linked to the treatment. However, it's important to note that these findings mainly apply to adults with CKD and type 2 diabetes, so differences may exist in children with CKD. Overall, the research suggests that finerenone is safe, which is why it is being tested in this trial for children. ^{1 2 3 4 5}

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

Finerenone is unique because it targets a different pathway in the body compared to standard treatments for chronic kidney disease, like ACE inhibitors or angiotensin receptor blockers (ARBs). It works by blocking mineralocorticoid receptors, which play a role in inflammation and scarring in the kidneys. This new approach could potentially offer better protection for kidney function and reduce associated risks, which is why researchers are excited about its potential.

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

Research has shown that finerenone can help treat chronic kidney disease (CKD). In studies with patients who had CKD and type 2 diabetes, finerenone lowered the risk of worsening kidney disease and reduced heart problems. A review of several studies also found that finerenone provides significant benefits for the kidneys and heart in CKD patients. While most research so far has focused on adults with both CKD and diabetes, the positive results suggest it might be useful for treating CKD more broadly. In this trial, participants will receive either finerenone or a placebo. Finerenone targets an overactive system in the body, helping manage protein in the urine and control blood pressure. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for children aged 6 months to under 18 years with chronic kidney disease and proteinuria, who are already taking optimized doses of ACE inhibitors or ARB medications. They must have stable kidney function and normal potassium levels. Children with recent severe kidney issues, certain blood pressure conditions, planned surgeries affecting kidneys, or those on specific immune treatments are excluded.

Inclusion Criteria

Your potassium levels must be within certain ranges when you are screened and on the first day of the study.

I have been diagnosed with chronic kidney disease.

My kidney function has been stable recently.

Exclusion Criteria

I have a kidney transplant.

I am scheduled for a surgery on my urinary system that may affect my kidney function.

I have nephrotic syndrome and received albumin infusions in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 104 days

2 visits (in-person)

Treatment

Participants receive either finerenone or placebo in addition to their normal ACEI or ARB treatment

180 days

At least 7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Finerenone

Trial Overview

The study tests if finerenone added to standard treatment (ACE inhibitor or ARB) better reduces urine protein in kids with chronic kidney disease than a placebo. It involves monitoring the drug's effects through regular health checks including blood and urine tests over approximately six months.

How Is the Trial Designed?

Group I: Finerenone (Kerendia, BAY94-8862) Experimental Treatment 1 Intervention

Participants will receive finerenone treatment.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo to finerenone.

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

Finerenone, a new selective nonsteroidal mineralocorticoid receptor antagonist, has been shown to significantly reduce adverse kidney and cardiovascular outcomes in adults with chronic kidney disease and Type II diabetes, based on randomized controlled trials.

While the incidence of hyperkalemia was higher in patients taking Finerenone compared to placebo, it was lower than that seen with older MRAs like spironolactone and eplerenone, and other adverse effects were similar between groups, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finerenone: A Novel Third-Generation Mineralocorticoid Receptor Antagonist. Gudino Flores, P., Rodriguez Salazar, JD., Nahar, BL., et al.[2023]

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

A study analyzing data from the FDA and a Japanese database found that certain antiosteoporotic drugs, like oral ibandronate and bazedoxifene, are associated with a decreased risk of acute kidney injury (AKI), suggesting they may be safer options for patients.

Conversely, oral alendronate was linked to a higher incidence of AKI, indicating that the risk of kidney injury can vary significantly among different osteoporosis medications, highlighting the need for careful selection and monitoring of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Antiosteoporotic Drugs and Risk of Acute Kidney Injury: A Cross-Sectional Study Using Disproportional Analysis and a Pharmacovigilance Database. Mitsuboshi, S., Kaseda, R., Narita, I.[2022]

In a study of 194 patients with End-Stage Renal Disease (ESRD), 14% experienced mortality within 72 hours of admission, highlighting the serious risks associated with advanced uremia and acidemia.

The most common adverse events included hypotension requiring inotropic support (20.6%) and seizures (16%), indicating that early intervention and referral for ESRD patients can significantly reduce morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of End-Stage Renal Disease Patients with Advanced Uremia and Acidemia. Rehman, IU., Idrees, MK., Shoukat, .[2017]

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]

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]

Gadolinium-based contrast agents, previously thought to be safe, can trigger nephrogenic systemic fibrosis (NSF) in patients with kidney failure, particularly with the unstable agent gadodiamide, which has a significantly higher prevalence of NSF (3-7%) compared to other agents (0-1%).

In patients with chronic kidney disease stage 5, the risk of developing NSF after two injections of gadodiamide can be as high as 36%, while no cases of NSF have been reported with the more stable gadolinium agents, indicating a critical difference in safety profiles among these contrast agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extracellular Gd-CA: differences in prevalence of NSF. Thomsen, HS., Marckmann, P.[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 5,674 patients with chronic kidney disease and type 2 diabetes, finerenone significantly reduced the risk of kidney and cardiovascular complications, regardless of baseline HbA1c levels or insulin use.

The treatment was well-tolerated, with similar rates of adverse events between finerenone and placebo groups, indicating its safety profile, particularly with low discontinuation rates due to hyperkalemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes According to Baseline HbA1c and Insulin Use: An Analysis From the FIDELIO-DKD Study. Rossing, P., Burgess, E., Agarwal, R., et al.[2023]

Finerenone significantly reduces urinary albumin-to-creatinine ratio and lowers the risk of end-stage kidney disease and cardiovascular events in patients with chronic kidney disease (CKD), based on a meta-analysis of five trials involving 13,078 participants.

While finerenone is associated with a higher risk of hyperkalemia (elevated potassium levels), it does not increase the overall incidence of adverse events compared to placebo, suggesting it is a promising treatment option for CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Finerenone in Chronic Kidney Disease: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Zhang, MZ., Bao, W., Zheng, QY., et al.[2022]

Out of 462,020 adverse event reports for small-molecule protein kinase inhibitors (PKIs), 9,970 cases (2.16%) were identified as acute kidney injury (AKI), with a median onset time of 32 days after treatment initiation.

Fourteen out of 52 small-molecule PKIs showed significant signals for AKI, with entrectinib, sirolimus, and cobimetinib having the highest reporting odds ratios, indicating a potential risk for kidney injury that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of acute kidney injury related to small-molecule protein kinase inhibitors using the FDA adverse event reporting system. Fan, Q., Ma, J., Zhang, B., et al.[2021]

Citations

1.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2025845

Effect of Finerenone on Chronic Kidney Disease Outcomes ...

In patients with CKD and type 2 diabetes, treatment with finerenone resulted in lower risks of CKD progression and cardiovascular events than placebo.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8859447/

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.

3.

frontiersin.org

frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2024.1476029/full

A comprehensive review of finerenone—a third-generation ...

Despite showing good safety and efficacy in T2DM-CKD patients, there are insufficient corresponding data for those presenting chronic kidney disease without ...

4.

accessdata.fda.gov

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

215341Orig1s000 - accessdata.fda.gov

Summary of Survival Data in Males (Study BAY 94-8862 in Rats) ... chronic kidney disease (CKD) and type 2 diabetes (T2D). Finerenone ...

5.

academic.oup.com

academic.oup.com/ndt/article/38/2/372/6572377

an analysis from the FIGARO-DKD study - Oxford Academic

In FIGARO-DKD, finerenone reduced the risk of cardiovascular events in patients with type 2 diabetes (T2D) and stage 1–4 chronic kidney disease (CKD).

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35034019/

Meta-Analysis of the Efficacy and Safety of Finerenone in ...

Analysis results demonstrated that patients receiving finerenone showed a significant decrease in changing urinary albumin-to-creatinine ratio ( ...

7.

nature.com

nature.com/articles/s41591-024-03264-4

Finerenone in heart failure and chronic kidney disease with ...

A previous pooled analysis of the CKD with T2D trials showed that finerenone reduced major adverse cardiovascular events by 14% and a kidney ...