What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) that involve mineralocorticoid receptor blockers (MRBs) like finerenone and spironolactone can have several side effects. These include hyperkalemia (elevated potassium levels), which can be serious and requires monitoring. Other potential side effects are gynecomastia (breast tissue enlargement in men), particularly with spironolactone, and possible feminization effects in male fetuses if taken during pregnancy. Additionally, there is a theoretical concern for an increased risk of breast cancer with spironolactone, although current evidence does not support a definitive link. Patients on these treatments should be closely monitored for these adverse effects.

What prior FDA approvals exist?

Finerenone, a mineralocorticoid receptor antagonist (MRA), has been approved for the treatment of chronic kidney disease (CKD) in patients with type 2 diabetes. Similar drugs include Spironolactone and Eplerenone, which are also MRAs used primarily for heart failure and hypertension. These drugs block the effects of aldosterone, reducing the risk of kidney and cardiovascular damage. The approval of these MRAs underscores their potential in managing CKD and its complications.

What other types of research exist?

Promising novel alternatives to Finerenone for CKD patients include Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, such as dapagliflozin and empagliflozin, which have shown benefits in reducing the progression of CKD and improving cardiovascular outcomes. Additionally, non-steroidal mineralocorticoid receptor antagonists like esaxerenone are being investigated for their potential benefits in CKD management.

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Mineralocorticoid Receptor Antagonist

Finerenone for Chronic Kidney Disease in Type 1 Diabetes (FINE-ONE Trial)

Q: What is the mechanism of action of this treatment?

Mineralocorticoid receptor blockers, such as finerenone, work by inhibiting the action of aldosterone, a hormone that can cause inflammation and fibrosis in the kidneys and heart. By blocking these receptors, finerenone reduces the risk of kidney disease progression and cardiovascular events. This is particularly important for CKD patients, as it helps to preserve kidney function and reduce complications. Other common treatments for CKD include angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), which lower blood pressure and reduce proteinuria, further protecting kidney function. These treatments collectively aim to slow the progression of CKD and improve patient outcomes.

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 with a clinical diagnosis of CKD and fulfilling both the criteria (central assessment): eGFR ≥25 and <90 mL/min/1.73 m^2 using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) 2009 formula at the Screening visit, UACR ≥200 mg/g (22.6 mg/mmol) to <5000 mg/g (565 mg/mmol) at the Screening visit (geometric mean of the 3 measurements)

Participant must be ≥18 years of age (or the legal age of consent according to local legislation) at the time of signing the informed consent.

Must not have

Participant with T2D (Type 2 diabetes).

Participant with mean BP (Blood pressure) higher than 160/100 mmHg or mean systolic BP lower than 90 mmHg at the Screening visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to 7 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing finerenone, a drug that helps protect kidneys and hearts, in people with chronic kidney disease and type 1 diabetes. The study aims to see how well finerenone works in slowing down kidney damage. Researchers will also monitor the safety of the drug by tracking any medical issues participants experience. Finerenone has been shown to delay the progression of chronic kidney disease and reduce cardiovascular events in patients with diabetic kidney disease, particularly type 2 diabetes.

Who is the study for?

Adults with Type 1 diabetes and chronic kidney disease (CKD) who are on stable blood pressure medication can join. They must have a certain level of kidney function, protein in urine, and controlled blood sugar levels. People with heart failure needing specific treatments or those recently on certain diabetes medications cannot participate.

What is being tested?

The trial is testing if Finerenone, which blocks proteins that may harm kidneys and the heart, is more effective than a placebo at slowing CKD progression in people with Type 1 diabetes. Participants will also continue their standard care treatments during the study.

What are the potential side effects?

Potential side effects include medical problems arising from treatment (TEAEs), serious TEAEs requiring hospitalization or causing disability, and high potassium levels in the blood (hyperkalaemia).

Eligibility Criteria

Inclusion Criteria

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

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I have chronic kidney disease with specific kidney function and protein levels.

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I am at least 18 years old or the legal age in my country.

Exclusion Criteria

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

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I have Type 2 diabetes.

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My blood pressure is either above 160/100 mmHg or below 90 mmHg systolic.

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I have not used SGLT-2/-1 inhibitors or GLP1 agonists in the last 8 weeks.

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I have heart failure with a need for specific heart medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 7 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Urinary albumin-to-creatinine ratio (UACR)

Secondary study objectives

Number of participants with Hyperkalaemia

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 armExperimental Treatment1 Intervention

Participants with eGFR ≥25 to \<60 mL/min/1.73 m\^2 at Screening visit will take Finerenone Dose A. Participants with eGFR ≥60 mL/min/1.73 m\^2 at Screening visit will take Dose B. Up-titration and down-titration of study intervention will be based on local potassium and kidney function (eGFR) values. Treatment duration is 6 months.

Group II: Placebo armPlacebo Group1 Intervention

Participants will take Finerenone matching placebo for 6 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Finerenone

2022

N/A

~250

0 / 6Eligibility 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

Mineralocorticoid receptor blockers, such as finerenone, work by inhibiting the action of aldosterone, a hormone that can cause inflammation and fibrosis in the kidneys and heart. By blocking these receptors, finerenone reduces the risk of kidney disease progression and cardiovascular events. This is particularly important for CKD patients, as it helps to preserve kidney function and reduce complications. Other common treatments for CKD include angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), which lower blood pressure and reduce proteinuria, further protecting kidney function. These treatments collectively aim to slow the progression of CKD and improve patient outcomes.

Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.Aldosterone antagonists for people with chronic kidney disease requiring dialysis.Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes.