Chronic Kidney Disease > Finerenone

Finerenone for Chronic Kidney Disease in Type 1 Diabetes

(FINE-ONE Trial)

Recruiting in Palo Alto (17 mi)

+128 other 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}

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.

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University Health Network (UHN) - Toronto General Hospital (TGH) Toronto, Canada

Unc Endocrinology At Eastowne Unc Hospitals Outpat Chapel Hill, SC

Northwestern Medical Group (Northwestern Medical Faculty Foundation) Chicago, IL

University of Texas Health San Antonio San Antonio, TX

More Trial Locations

Who Is Running the Clinical Trial?

Bayer Lead Sponsor

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] Despite guideline-recommended treatments, including renin angiotensin system inhibition, up to 40 % of individuals with type 1 diabetes develop chronic kidney disease (CKD) putting them at risk of kidney failure. Finerenone is approved to reduce the risk of kidney failure in individuals with type 2 diabetes. We postulate that finerenone will demonstrate benefits on kidney outcomes in people with type 1 diabetes.

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] Finerenone (Kerendia) has been approved to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.

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] Finerenone significantly improved cardiorenal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease trial. We explored whether baseline HbA1c level and insulin treatment influenced outcomes.

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

Finerenone: First Approval. [2022] Finerenone (Kerendia&#174;), a first-in-class, orally administered, selective, nonsteroidal mineralocorticoid receptor antagonist (MRA), is being developed by Bayer HealthCare Pharmaceuticals for the treatment of diabetic kidney disease (DKD) and heart failure (HF), including chronic HF (CHF). Finerenone has been approved in the USA to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end stage renal disease (ESRD), cardiovascular death, nonfatal myocardial infarction (MI), and hospitalization for HF in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). Finerenone is undergoing regulatory assessment in the EU and in China. A phase III trial is investigating finerenone in patients who have HF with preserved ejection fraction. This article summarizes the milestones in the development of finerenone leading to this first approval to reduce the risk of serious kidney and heart complications in adults with CKD and T2D.

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

Finerenone in diabetic kidney disease: A systematic review and critical appraisal. [2022] Finerenone is a novel non-steroidal mineralocorticoid antagonist (MRA) recently approved for the treatment of chronic kidney disease (CKD) in people with type 2 diabetes (T2D). We aim to conduct a systematic review of finerenone to know the efficacy and safety of finerenone in CKD with or without T2D.

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

Hyperkalemia Risk with Finerenone: Results from the FIDELIO-DKD Trial. [2023] Finerenone reduced risk of cardiorenal outcomes in patients with CKD and type 2 diabetes in the FIDELIO-DKD trial. We report incidences and risk factors for hyperkalemia with finerenone and placebo in FIDELIO-DKD.

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] Finerenone, a new nonsteroidal mineralocorticoid receptor antagonist, showed a significant reduction in a primary composite renal outcome in FIDELIO-DKD and a significant reduction in a primary composite cardiovascular outcome in FIGARO-DKD in patients with type 2 diabetes (T2D) and a chronic kidney disease (CKD). In a subsequent analysis that combined these two clinical trials (FIDELITY), the reduction becomes statistically significant when compared to placebo for both outcomes, with a hazard ratio of 0.86 (95 % confidence interval 0.78-0.95; P = 0.0018) for the cardiovascular outcome and 0.77 (0.67-0.88; P = 0.0002) for the renal outcome. Furthermore, all renal events occurred less frequently with finerenone than with placebo, including the progression to end-stage CKD independently of the baseline levels of glomerular filtration rate and albuminuria and regardless of associated medications (including gliflozins). The safety profile was excellent. However, a significant increase in serum potassium level was observed. Even if it is less pronounced than the increase usually seen with spironolactone, the risk of hyperkalemia requires some caution regarding both patient selection and monitoring. Finerenone (Kerendia®) is indicated in the treatment of CKD with albuminuria in adult patients with T2D. In Belgium, it is reimbursed with conditions in combination with a renin-angiotensin blocker.