Finerenone for Chronic Kidney Disease in Type 1 Diabetes

(FINE-ONE Trial)

No longer recruiting at 169 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: SGLT-2, GLP1

Disqualifiers: Type 2 diabetes, Hypertension, Heart failure, 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: 7

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of finerenone, a new treatment for individuals with chronic kidney disease (CKD) and type 1 diabetes. CKD often develops when kidneys gradually lose function, frequently due to high blood sugar levels from type 1 diabetes. The study compares finerenone to a placebo to determine if it can prevent the progression of kidney problems. Participants must have type 1 diabetes managed with insulin and already experience CKD. The trial also assesses the safety of finerenone by monitoring any health issues it may cause. As a Phase 3 trial, this study represents the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

No, you will not have to stop taking your current medications. Participants will continue their regular standard of care (SOC) medicines during the trial.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, you will continue to take your regular standard of care medicines during the study.

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

Research has shown that finerenone is generally safe for people with chronic kidney disease (CKD) and type 2 diabetes. Studies have found that it can slow kidney damage and reduce heart problems compared to a placebo. Finerenone has received approval for patients with CKD and type 2 diabetes, indicating a certain level of safety. However, less information exists about its safety for people with type 1 diabetes, so researchers continue to study this. Some studies have reported side effects, such as higher potassium levels in the blood, known as hyperkalemia, which doctors will monitor during the study. Overall, while finerenone has demonstrated good safety and effectiveness in other conditions, this trial will help determine its safety for people with CKD and type 1 diabetes. ^{1 2 3 4 5}

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

Finerenone is unique because it offers a novel approach to managing chronic kidney disease (CKD) in individuals with Type 1 diabetes. Unlike most current treatments that primarily focus on controlling blood sugar and blood pressure, Finerenone works by blocking mineralocorticoid receptors, which play a key role in inflammation and fibrosis in the kidneys. This new mechanism of action could potentially slow down kidney damage more effectively, offering hope for better long-term kidney health in patients with Type 1 diabetes. Researchers are excited about Finerenone because it targets the underlying processes that contribute to kidney disease progression, rather than just the symptoms.

What evidence suggests that finerenone might be an effective treatment for chronic kidney disease in type 1 diabetes?

Research has shown that finerenone, which participants in this trial may receive, effectively treats chronic kidney disease (CKD) in people with type 2 diabetes. Studies have found that it can lower the risk of CKD progression and reduce heart-related problems. Finerenone blocks certain proteins that can damage the kidneys and heart when overly active. While most research focuses on people with type 2 diabetes, the mechanism of finerenone suggests it might also benefit those with type 1 diabetes who have CKD. Its approval for use in CKD with type 2 diabetes indicates its potential in similar conditions. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your potassium levels are within a certain range when tested at the local clinic.

I was diagnosed with diabetes after 35 and have specific diabetes-related antibodies or had a severe diabetes complication.

I have been on a steady dose of ACEI or ARB medication for at least 4 weeks.

Exclusion Criteria

I have Type 2 diabetes.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Finerenone or placebo in addition to standard of care for 6 months

6 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1.5 months

What Are the Treatments Tested in This Trial?

Interventions

• Finerenone
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Finerenone arm Experimental Treatment 1 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 arm Placebo Group 1 Intervention

Participants will take Finerenone matching placebo for 6 months.

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

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 (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]

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]

The FINE-ONE trial is a phase III study involving approximately 220 adults with type 1 diabetes, aiming to evaluate the efficacy and safety of finerenone over 7.5 months, particularly focusing on its impact on kidney health as measured by urine albumin/creatinine ratio (UACR).

If successful, finerenone could be the first new treatment registered for chronic kidney disease associated with type 1 diabetes in nearly 30 years, addressing a significant gap in current treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial. Heerspink, HJL., Birkenfeld, AL., Cherney, DZI., et al.[2023]

Finerenone, a new non-steroidal mineralocorticoid antagonist, shows better renal outcomes compared to spironolactone and improved mortality outcomes compared to eplerenone in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), with fewer instances of hyperkalemia.

In long-term studies, finerenone significantly reduces the progression of renal disease and cardiovascular events, particularly heart failure hospitalizations, without affecting HbA1c, body weight, or causing sexual side effects, although it does have a higher rate of hyperkalemia leading to drug withdrawal compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finerenone in diabetic kidney disease: A systematic review and critical appraisal. Singh, AK., Singh, A., Singh, R., et al.[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]

Finerenone significantly reduces the risk of both cardiovascular and renal outcomes in patients with type 2 diabetes and chronic kidney disease, as shown in combined analyses of the FIDELIO-DKD and FIGARO-DKD trials, with hazard ratios indicating a strong efficacy compared to placebo.

While finerenone has an excellent safety profile, it does carry a risk of increased serum potassium levels, necessitating careful patient selection and monitoring, especially when used alongside other medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Finerenone (Kerendia®), a new weapon against the chronic kidney disease of a patient with type 2 diabetes]. Scheen, A., Delanaye, P.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12171220/

Finerenone in diabetic kidney disease: a new frontier for ... Finerenone, a non-steroidal mineralocorticoid receptor antagonist (MRA), represents a novel approach to the management of DKD.

2. 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.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07026539?aggFilters=status%3A

Effect of Treatment With Finerenone on Cardio-Renal ... In large clinical trials, the novel drug finerenone has shown to lower the risk of chronic kidney disease progression and improve the cardiovascular outcome for ...

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

Finerenone in heart failure and chronic kidney disease with ... Finerenone has been shown to reduce the risk of cardiovascular events and kidney failure in patients with CKD with type 2 diabetes (T2D) and has ...

5. 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 ...

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

Meta-Analysis of the Efficacy and Safety of Finerenone in ... Finerenone contributes to the reduction of UACR and can ameliorate the deterioration of renal function in patients with T2D and CKD.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06278207?term=FINERENONE&rank=6

NCT06278207 | An Observational Study Called FINEROD ... The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as ...