Finerenone for Chronic Kidney Disease

(FIND-CKD Trial)

Not currently recruiting at 649 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bayer

Must be taking: ACEI, ARB

Must not be taking: MRAs

Disqualifiers: Diabetes, Polycystic kidney, Lupus, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 32 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called finerenone for individuals with non-diabetic chronic kidney disease (non-diabetic CKD). Finerenone aims to slow kidney damage by blocking a hormone that harms the kidney and heart. Participants will receive either finerenone or a placebo (a look-alike pill with no active medicine) while continuing their regular kidney medication. Suitable candidates have non-diabetic CKD, have taken certain kidney medications for at least four weeks, and do not have diabetes or specific other kidney conditions. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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 there any evidence suggesting that finerenone is likely to be safe for humans?

Research has shown that finerenone has been studied in people with chronic kidney disease (CKD) and type 2 diabetes. The results indicated that finerenone lowered the risk of CKD worsening and reduced heart-related problems compared to a placebo. This suggests that finerenone might benefit kidney and heart health.

Regarding safety, studies have examined how well people tolerate finerenone. The findings suggest it generally leads to fewer kidney and heart issues. However, like any treatment, it can have side effects, which clinical trials monitor closely.

Since researchers have tested finerenone in many patients, there is extensive information about its safety. People considering joining a trial should know that doctors will monitor any health changes to ensure safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic kidney disease?

Finerenone is unique because it targets the mineralocorticoid receptor, which plays a key role in inflammation and fibrosis in the kidneys. Unlike standard treatments for chronic kidney disease, such as ACE inhibitors and ARBs, which primarily focus on reducing blood pressure and proteinuria, finerenone directly modulates this receptor to potentially reduce kidney damage. Researchers are excited about finerenone because it offers a novel mechanism of action that could provide additional protection for kidney function, potentially slowing the progression of the disease more effectively than current options.

What evidence suggests that finerenone might be an effective treatment for non-diabetic CKD?

Research shows that finerenone, which participants in this trial may receive, can help slow chronic kidney disease (CKD), especially in people with type 2 diabetes. Studies have found that it reduces the risk of worsening kidney problems and lowers heart-related issues in these patients. While strong evidence supports its benefits for people with diabetes, less information exists for those with CKD who don't have diabetes. However, finerenone blocks a hormone called aldosterone, which can damage the kidneys and heart. This suggests it might also protect the kidneys in people with non-diabetic CKD. ^{1 5 6 7 8}

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.

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.

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?

Group I: Finerenone (BAY94-8862) Experimental Treatment 1 Intervention

Participants will receive finerenone.

Group II: Placebo Placebo Group 1 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

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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 the FIDELIO-DKD trial, 21.4% of patients treated with finerenone experienced mild hyperkalemia compared to 9.2% in the placebo group, indicating a higher risk of elevated potassium levels with finerenone.

Despite the increased risk of hyperkalemia associated with finerenone, effective monitoring and management strategies were implemented, which helped minimize its impact and support the safe clinical use of the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperkalemia Risk with Finerenone: Results from the FIDELIO-DKD Trial. Agarwal, R., Joseph, A., Anker, SD., et al.[2023]

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]

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]

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]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2025845

Effect of Finerenone on Chronic Kidney Disease Outcomes ... In patients with CKD and type 2 diabetes, treatment with finerenone resulted in lower risks of CKD progression and cardiovascular events than placebo.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8859447/

Efficacy and Safety of Finerenone in Chronic Kidney Disease Conclusion: Data from our meta-analysis suggest that finerenone confers significant renal and cardiovascular benefits in patients with CKD.

3. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2024.1476029/full

A comprehensive review of finerenone—a third-generation ... Despite showing good safety and efficacy in T2DM-CKD patients, there are insufficient corresponding data for those presenting chronic kidney disease without ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2021/215341Orig1s000IntegratedR.pdf

215341Orig1s000 - accessdata.fda.gov chronic kidney disease (CKD) and type 2 diabetes (T2D). Finerenone does not lower arterial blood pressure at doses that slow the progression ...

5. nature.com nature.com/articles/s41591-024-03264-4

Finerenone in heart failure and chronic kidney disease with ... A previous pooled analysis of the CKD with T2D trials showed that finerenone reduced major adverse cardiovascular events by 14% and a kidney ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35034019/

Meta-Analysis of the Efficacy and Safety of Finerenone in ... Analysis results demonstrated that patients receiving finerenone showed a significant decrease in changing urinary albumin-to-creatinine ratio ( ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31583611/

Insights Based on Phase IIb Data and Simulations to ... We present the population pharmacokinetics and pharmacodynamics (PD) analysis for efficacy and safety markers based on data from two clinical phase IIb studies.

8. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.819327/full

Efficacy and Safety of Finerenone in Chronic Kidney Disease Conclusion: Data from our meta-analysis suggest that finerenone confers significant renal and cardiovascular benefits in patients with CKD.