What is the mechanism of action of this treatment?

Common treatments for Chronic Kidney Disease (CKD) often target the renin-angiotensin-aldosterone system (RAAS) to control blood pressure and reduce proteinuria, both critical in slowing CKD progression. ACE inhibitors (ACEI) and angiotensin receptor blockers (ARB) inhibit different parts of RAAS, reducing its overactivity. Finerenone, a non-steroidal mineralocorticoid receptor antagonist, blocks the effects of aldosterone, another RAAS component, potentially offering additional benefits in managing CKD. These treatments are essential as they help improve kidney function and delay disease progression.

What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) that modulate the Renin-Angiotensin-Aldosterone System (RAAS), such as ACE inhibitors (ACEI) and Angiotensin Receptor Blockers (ARB), are known to cause side effects including elevated blood potassium levels (hyperkalemia), low blood pressure (hypotension), dizziness, and kidney dysfunction. ACE inhibitors may also cause a persistent cough and both ACEI and ARBs can lead to angioedema, a serious swelling beneath the skin. Finerenone, a newer RAAS modulator, is expected to have similar side effects, particularly hyperkalemia and changes in kidney function.

What prior FDA approvals exist?

For the treatment of Chronic Kidney Disease (CKD), the FDA has approved several drugs that modulate the renin-angiotensin-aldosterone system (RAAS). These include angiotensin-converting enzyme inhibitors (ACE inhibitors) such as enalapril and lisinopril, and angiotensin receptor blockers (ARBs) like losartan and valsartan. These medications help improve kidney function by reducing proteinuria and controlling blood pressure, thereby slowing the progression of CKD. Finerenone, currently under study, is another RAAS modulator that aims to provide additional benefits when used alongside ACE inhibitors or ARBs.

What other types of research exist?

Promising, novel alternatives to Finerenone for CKD patients include: 1) SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) which have shown benefits in reducing proteinuria and slowing CKD progression. 2) Endothelin receptor antagonists (e.g., atrasentan) which target proteinuria and have shown potential in clinical trials. 3) Novel mineralocorticoid receptor antagonists (e.g., esaxerenone) which offer similar benefits to Finerenone with potentially different safety profiles. Patients should discuss these options with their healthcare provider to determine the best treatment plan.

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Mineralocorticoid Receptor Antagonist

Finerenone for Chronic Kidney Disease (FIONA Trial)

Phase 3

Recruiting

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening

Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed

Must not have

Renal allograft in place

Planned urological surgery expected to influence renal function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects of finerenone may include high potassium levels, low blood pressure, dizziness, changes in heart rhythm or rate; as it affects RAAS which controls these functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with chronic kidney disease.

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I am between 6 months and 18 years old.

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My kidney function has been stable recently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a kidney transplant.

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

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I needed dialysis for kidney injury within the last 6 months.

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I am a candidate for a kidney transplant.

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My child over 1 year old has severe high blood pressure.

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My blood pressure is very low for my age, sex, and height.

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I have narrowing in the arteries of both my kidneys.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Urinary protein-to-creatinine ratio (UPCR) reduction of at least 30% from baseline to day 180±7

Secondary study objectives

Change in UACR from baseline to day 180±7

Change in eGFR from baseline to day 180±7

Mean reduction from baseline to day 180±7 in UPCR

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Finerenone (Kerendia, BAY94-8862)Experimental Treatment1 Intervention

Participants will receive finerenone treatment.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo to finerenone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Finerenone (Kerendia, BAY94-8862)

2021

Completed Phase 2

~18800

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Kidney Disease (CKD) often target the renin-angiotensin-aldosterone system (RAAS) to control blood pressure and reduce proteinuria, both critical in slowing CKD progression. ACE inhibitors (ACEI) and angiotensin receptor blockers (ARB) inhibit different parts of RAAS, reducing its overactivity. Finerenone, a non-steroidal mineralocorticoid receptor antagonist, blocks the effects of aldosterone, another RAAS component, potentially offering additional benefits in managing CKD. These treatments are essential as they help improve kidney function and delay disease progression.

Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.