1584 Participants Needed

Finerenone for Chronic Kidney Disease

(FIND-CKD Trial)

Recruiting at 561 trial locations
BC
Overseen ByBayer Clinical Trials Contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Bayer
Must be taking: ACEI, ARB
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing finerenone, a daily pill, to help people with non-diabetic chronic kidney disease. Finerenone works by blocking a hormone called aldosterone that can cause damage and swelling in the heart and kidneys. The goal is to see if finerenone can slow down the worsening of kidney disease. Finerenone has shown promise in reducing kidney disease progression in patients with chronic kidney disease and type 2 diabetes.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications for chronic kidney disease. Participants will continue their existing CKD medications while taking the trial treatment.

Is Finerenone safe for humans?

There is no specific safety data for Finerenone in the provided research articles.12345

What makes the drug Finerenone unique for treating chronic kidney disease?

Finerenone is unique because it is a first-in-class, third-generation, nonsteroidal mineralocorticoid receptor antagonist (MRA) that 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), making it a safer option for long-term use.678910

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

Finerenone has been shown to reduce the risk of worsening kidney function and heart-related complications in people with chronic kidney disease and type 2 diabetes. Studies have demonstrated its effectiveness in improving kidney and heart health outcomes compared to a placebo.678911

Are You a Good Fit for This Trial?

Adults with non-diabetic chronic kidney disease (CKD) can join this trial. They must have a certain level of protein in their urine and a specific range of kidney function. Participants should be on stable doses of ACE inhibitors or ARBs for at least 4 weeks before the trial starts, without severe heart failure or diabetes, and not require immunosuppressive therapy for other kidney diseases.

Inclusion Criteria

My kidney tests show specific levels of protein in my urine and a certain rate of filtration.
I have been diagnosed with chronic kidney disease.
I have been on a stable dose of ACEI or ARB medication for at least 4 weeks.
See 2 more

Exclusion Criteria

I have a genetic form of polycystic kidney disease.
I have a kidney condition treated with immune-suppressing drugs in the last 6 months.
I have been diagnosed with Type 1 or Type 2 Diabetes, or my HbA1c level is 6.5% or higher.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive finerenone or placebo once a day as tablets by mouth, in addition to their current CKD medication

32 months
Regular visits for blood and urine samples, health checks, and adverse event monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Finerenone
  • Placebo
Trial Overview The trial is testing if finerenone, a tablet taken once daily that blocks the hormone aldosterone, can slow down CKD progression compared to a placebo. The study will last up to about 50 months and involves regular health checks plus blood and urine tests while continuing current CKD medications.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Finerenone (BAY94-8862)Experimental Treatment1 Intervention
Participants will receive finerenone.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.

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

Find a Clinic Near You

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 profile image

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Published Research Related to This Trial

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.
New Type 2 Diabetes Drug AIMS to Reduce Risk of Diminished Kidney Function and Cardiovascular Complications.Aschenbrenner, DS.[2023]
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.
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.
Finerenone in Hispanic Patients With CKD and Type 2 Diabetes: A Post Hoc FIDELITY Analysis.Rosas, SE., Ruilope, LM., Anker, SD., et al.[2023]

Citations

New Type 2 Diabetes Drug AIMS to Reduce Risk of Diminished Kidney Function and Cardiovascular Complications. [2023]
Finerenone: First Approval. [2022]
Finerenone in Hispanic Patients With CKD and Type 2 Diabetes: A Post Hoc FIDELITY Analysis. [2023]
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]
Finerenone: A Novel Third-Generation Mineralocorticoid Receptor Antagonist. [2023]
Patient-reported and actionable safety events in CKD. [2021]
Extracellular Gd-CA: differences in prevalence of NSF. [2022]
Outcome of End-Stage Renal Disease Patients with Advanced Uremia and Acidemia. [2017]
Association Between Antiosteoporotic Drugs and Risk of Acute Kidney Injury: A Cross-Sectional Study Using Disproportional Analysis and a Pharmacovigilance Database. [2022]
Assessment of acute kidney injury related to small-molecule protein kinase inhibitors using the FDA adverse event reporting system. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Hyperkalemia Risk with Finerenone: Results from the FIDELIO-DKD Trial. [2023]
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