Finerenone for Chronic Kidney Disease in Type 1 Diabetes

(FINE-ONE Trial)

Recruiting at131 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bayer

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that Finerenone for Chronic Kidney Disease in Type 1 Diabetes is an effective drug?

The available research shows that Finerenone is approved to help reduce the risk of kidney failure in people with type 2 diabetes. However, there is no specific data provided about its effectiveness for chronic kidney disease in type 1 diabetes. The research mentions a trial investigating its potential benefits for type 1 diabetes, but no results are shared. Therefore, while it is effective for type 2 diabetes, we don't have enough information to confirm its effectiveness for type 1 diabetes. ^{1 2 3 4 5}

What safety data is available for Finerenone in treating chronic kidney disease?

Finerenone, also known as Kerendia, has been approved for use in patients with chronic kidney disease associated with type 2 diabetes to reduce risks of kidney and cardiovascular complications. Safety data from the FIDELIO-DKD trial indicates that Finerenone significantly improved cardiorenal outcomes but also highlighted a risk of hyperkalemia. The drug is currently being investigated for use in type 1 diabetes with chronic kidney disease in the FINE-ONE trial. ^{1 2 3 4 6}

Is the drug Finerenone a promising treatment for chronic kidney disease in people with type 1 diabetes?

Finerenone is a promising drug for chronic kidney disease in people with type 1 diabetes because it has shown benefits in reducing the risk of kidney failure in people with type 2 diabetes. Researchers believe it could have similar positive effects for those with type 1 diabetes. ^{1 2 4 5 7}

Research Team

Eligibility Criteria

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.

Treatment Details

Interventions

• Finerenone (Mineralocorticoid Receptor Antagonist)
• Placebo (Other)

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.

Participant Groups

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.

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

Findings from Research

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 (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]

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 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]

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]

References

1. Ireland 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Finerenone: First Approval. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Finerenone in diabetic kidney disease: A systematic review and critical appraisal. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Hyperkalemia Risk with Finerenone: Results from the FIDELIO-DKD Trial. [2023]

7. Belgium pubmed.ncbi.nlm.nih.gov

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