What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) that target RAAS overactivation, such as ACE inhibitors (ACEI), angiotensin receptor blockers (ARB), and finerenone, often have side effects including hyperkalemia (elevated potassium levels), hypotension (low blood pressure), and potential deterioration of renal function. Finerenone, in particular, may also pose risks of cardiovascular issues. Regular monitoring of blood pressure, serum potassium, and renal function is crucial during these treatments.

What prior FDA approvals exist?

For the treatment of Chronic Kidney Disease (CKD), the FDA has approved angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB). These medications help manage CKD by reducing the activity of the renin-angiotensin-aldosterone system (RAAS), which is often overactive in CKD patients. By controlling RAAS activity, ACEI and ARB help lower blood pressure and reduce proteinuria, thereby improving kidney function. Finerenone, currently under study, aims to further enhance RAAS control when used in combination with ACEI or ARB.

What other types of research exist?

Promising novel alternatives to Finerenone for CKD patients include SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin), which have shown benefits in reducing proteinuria and slowing CKD progression. Additionally, non-steroidal mineralocorticoid receptor antagonists (e.g., esaxerenone) and endothelin receptor antagonists (e.g., atrasentan) are being investigated for their potential benefits in CKD management.

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Mineralocorticoid Receptor Antagonist

Finerenone for Pediatric Chronic Kidney Disease (FIONA OLE Trial)

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

Common treatments for Chronic Kidney Disease (CKD) often target the renin-angiotensin-aldosterone system (RAAS), which regulates blood pressure and fluid balance. Overactivation of RAAS can worsen CKD by causing hypertension and proteinuria. ACE inhibitors (ACEI) and angiotensin receptor blockers (ARB) reduce RAAS activity, lowering blood pressure and proteinuria. Finerenone, a non-steroidal mineralocorticoid receptor antagonist, blocks aldosterone's effects, providing additional RAAS control. This comprehensive approach is crucial for CKD patients to slow disease progression and manage symptoms effectively.

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 be ≥1 year to 18 years of age, at the time of signing the informed consent/assent

Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding

Must not have

Concomitant therapy with a mineralocorticoid receptor antagonist (MRA)(eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any sodium-glucose co-transporter-2 (SGLT2) inhibitor (SGLT2i), sacubitril/valsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene)

Systemic hypotension defined as symptomatic hypotension or a mean systolic BP below the 5th percentile for age, sex and height but no lower than 80 mmHg for participants <18 years and symptomatic hypotension or a mean systolic blood pressure (SBP) <90 mmHg in participants ≥18 years at Visit 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

All Individual Drugs Already Approved

Summary

This trial tests finerenone, a new medication added to existing treatments, to help children with chronic kidney disease (CKD) and proteinuria. It aims to see if finerenone can better control kidney function and reduce protein in the urine. The study will monitor safety and effectiveness over several months. Finerenone has been shown to delay the progression of chronic kidney disease.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Possible side effects include changes in electrolyte levels like potassium which can affect heart rhythm, low blood pressure symptoms if they occur, allergic reactions to medication components, as well as other potential treatment-related medical problems.

Eligibility Criteria

Inclusion Criteria

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

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I am between 1 and 18 years old.

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I can eat solid food or receive nutrition through a feeding tube.

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I am of legal age and can sign my own consent.

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I have been on a stable dose of ACEI or ARB for blood pressure for at least 30 days.

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I have been diagnosed with early-stage chronic kidney disease.

Exclusion Criteria

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

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I am currently taking specific heart or blood pressure medications.

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I have low blood pressure according to my age, sex, and height.

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My liver is not working well (severe issues).

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I am not taking strong medications that affect liver enzymes.

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I am scheduled for a kidney transplant during the study.

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I stopped a study treatment permanently due to a serious side effect in the FIONA study.

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I am currently using medications like rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids.

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My blood pressure is very high according to my doctor's guidelines.

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

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I am taking both ACE inhibitors and ARBs medications together.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Finerenone Open-Label safety ExtensionExperimental Treatment1 Intervention

Participants will receive finerenone treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Finerenone

FDA approved

0 / 15Eligibility 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), which regulates blood pressure and fluid balance. Overactivation of RAAS can worsen CKD by causing hypertension and proteinuria. ACE inhibitors (ACEI) and angiotensin receptor blockers (ARB) reduce RAAS activity, lowering blood pressure and proteinuria. Finerenone, a non-steroidal mineralocorticoid receptor antagonist, blocks aldosterone's effects, providing additional RAAS control. This comprehensive approach is crucial for CKD patients to slow disease progression and manage symptoms effectively.

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