Finerenone for Chronic Kidney Disease

(FIONA Trial)

Recruiting at206 trial locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Bayer

Must be taking: ACEI, ARB

Must not be taking: Rituximab, Cyclophosphamide

Disqualifiers: Planned urological surgery, Nephrotic syndrome, others

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing whether adding finerenone to existing treatments can help children with chronic kidney disease and proteinuria. The study will measure if finerenone can reduce the amount of protein in their urine and improve kidney function. Children will continue their usual medications and be monitored through various health checks and tests. Finerenone has been shown to delay the progression of chronic kidney disease.

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.

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

Finerenone has been shown to improve kidney and heart health in people with chronic kidney disease and type 2 diabetes by reducing the risk of kidney failure, heart-related deaths, and hospitalizations for heart failure. It is a newer type of drug that works by blocking certain hormones that can harm the kidneys and heart. ^{1 2 3 4 5}

Is Finerenone safe for humans?

There is no specific safety data for Finerenone in the provided research articles. ^{6 7 8 9 10}

How is the drug Finerenone unique for treating chronic kidney disease?

Finerenone is unique because it is a first-in-class, nonsteroidal mineralocorticoid receptor antagonist (MRA) that is taken orally and specifically targets kidney and heart complications in patients with chronic kidney disease and type 2 diabetes. Unlike older MRAs, it has a lower risk of causing hyperkalemia (high potassium levels) and offers significant benefits in reducing kidney and cardiovascular issues. ^{1 2 3 5 11}

Research Team

Eligibility Criteria

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.

I am between 6 months and 18 years old.

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.

Trial Timeline

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)

Treatment Details

Interventions

• Finerenone (Mineralocorticoid Receptor Antagonist)

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.

Participant Groups

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.

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

Findings from Research

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]

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, 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. New Zealand pubmed.ncbi.nlm.nih.gov

Finerenone: First Approval. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Finerenone in Hispanic Patients With CKD and Type 2 Diabetes: A Post Hoc FIDELITY Analysis. [2023]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Finerenone: A Novel Third-Generation Mineralocorticoid Receptor Antagonist. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Extracellular Gd-CA: differences in prevalence of NSF. [2022]

8. Pakistan pubmed.ncbi.nlm.nih.gov

Outcome of End-Stage Renal Disease Patients with Advanced Uremia and Acidemia. [2017]

9. England 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. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Assessment of acute kidney injury related to small-molecule protein kinase inhibitors using the FDA adverse event reporting system. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Finerenone in Chronic Kidney Disease: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. [2022]