Finerenone + Empagliflozin for Chronic Kidney Disease and Type 2 Diabetes

(CONFIDENCE Trial)

Recruiting at 258 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bayer

Must be taking: Ace inhibitors, Arbs

Must not be taking: Sglt2 inhibitors, Mr antagonists

Disqualifiers: Type 1 diabetes, Hepatic insufficiency, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 7

Duration: 24 weeks

1664 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if combining finerenone and empagliflozin can better slow down kidney damage in patients with CKD and T2D compared to using each drug alone. Finerenone protects kidneys, while empagliflozin lowers blood sugar. Empagliflozin has shown significant improvements in glycemic control, body weight, and blood pressure, and finerenone has demonstrated improved outcomes in patients with chronic kidney disease and type 2 diabetes. The study will measure protein levels in urine to assess effectiveness.

Will I have to stop taking my current medications?

You can continue taking your current medications for chronic kidney disease and type 2 diabetes, but you must stop taking certain medications like SGLT2 inhibitors and mineralocorticoid receptor antagonists at least 8 weeks before the study.

What data supports the effectiveness of the drug combination of Finerenone and Empagliflozin for chronic kidney disease and type 2 diabetes?

Research shows that Finerenone can reduce the risk of kidney and heart problems in people with chronic kidney disease and type 2 diabetes. Additionally, combining Finerenone with SGLT2 inhibitors like Empagliflozin is considered promising for protecting the heart and kidneys due to their different ways of working. ^{1 2 3 4 5}

Is the combination of Finerenone and Empagliflozin safe for humans?

Empagliflozin (Jardiance) is generally well-tolerated and has been used safely in people with type 2 diabetes and chronic kidney disease, though it can cause side effects like genital infections and low blood pressure. It is important for healthcare providers to monitor for these effects, especially in patients at risk for fluid deficits. ^{6 7 8 9 10}

What makes the drug combination of Finerenone and Empagliflozin unique for treating chronic kidney disease and type 2 diabetes?

This drug combination is unique because Finerenone is a first-in-class, nonsteroidal mineralocorticoid receptor antagonist that helps reduce the risk of kidney and heart complications, while Empagliflozin is a sodium-glucose cotransporter 2 inhibitor that helps lower blood sugar and protect kidney function. Together, they offer a novel approach to managing both kidney and cardiovascular risks in patients with chronic kidney disease and type 2 diabetes. ^{2 3 5 11 12}

Eligibility Criteria

Adults with chronic kidney disease and type 2 diabetes can join this trial. They should have a certain level of protein in their urine, stable kidney function within specific limits, and controlled blood sugar levels. Participants must be on ACE inhibitors or ARBs for at least a month but not both. Those with very high or low blood pressure, severe liver issues, or taking certain other medications are excluded.

Inclusion Criteria

My kidney function is reduced but not severely, based on recent tests.

My kidney function is moderately reduced but not severely, based on recent tests.

I have type 2 diabetes with an HbA1c level below 11%.

Exclusion Criteria

Your blood test shows high potassium levels above 4.8 mmol/L.

I am not taking certain heart or blood pressure medicines that can't be stopped for 8 weeks.

I have been treated with Finerenone within the last 8 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the combination of Finerenone and Empagliflozin, or one of the drugs with a placebo for 6 months

24 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Empagliflozin
• Finerenone

Trial Overview The study tests how well finerenone combined with empagliflozin works compared to each one alone in slowing down kidney function decline in participants. It measures the effect by checking protein levels in urine while maintaining other CKD and T2D treatments over a period of up to 7.5 months.

Participant Groups

Group I: Finerenone and Empagliflozin placebo Experimental Treatment 3 Interventions

Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.

Group II: Finerenone and Empagliflozin Experimental Treatment 3 Interventions

Participants will take Finerenone (10 or 20 mg once daily \[OD\]) and Empagliflozin (10 mg OD) for up to 180 days.

Group III: Empagliflozin and Finerenone placebo Experimental Treatment 2 Interventions

Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD). for up to 180 days.

Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction
• Chronic kidney disease

Approved in United States as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction
• Chronic kidney disease
• Cardiovascular risk reduction

Approved in Canada as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction
• Chronic kidney disease

Approved in Japan as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction

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

In a study of 5674 patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), finerenone significantly reduced urine albumin-to-creatinine ratio (UACR) regardless of whether patients were also using sodium-glucose cotransporter-2 inhibitors (SGLT-2i).

Finerenone demonstrated consistent benefits on kidney and cardiovascular outcomes compared to placebo, with improved safety profile, particularly showing fewer hyperkalemia events in patients using SGLT-2i.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finerenone in Predominantly Advanced CKD and Type 2 Diabetes With or Without Sodium-Glucose Cotransporter-2 Inhibitor Therapy. Rossing, P., Filippatos, G., 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]

Empagliflozin (Jardiance) is now approved for reducing the risk of cardiovascular death and hospitalization in adults with heart failure, even in those without diabetes, highlighting its expanded therapeutic use.

Healthcare providers, including nurses and nurse practitioners, should closely monitor patients for potential adverse effects, particularly fluid deficits, to ensure patient safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Drug Now Approved for Heart Failure. Aschenbrenner, DS.[2023]

Empagliflozin (Jardiance®) is an effective treatment for type 2 diabetes (T2D) that works by inhibiting the sodium glucose cotransporter-2 (SGLT2), and it also offers cardioprotective and renoprotective benefits, making it particularly suitable for patients with cardiovascular disease (CVD) and chronic kidney disease (CKD).

While empagliflozin is generally well-tolerated and easy to administer, it does have some side effects and contraindications that need to be considered, highlighting the importance of evaluating its benefits against potential risks in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dual role of empagliflozin: Cardio renal protection in T2DM patients. Shafiq, A., Mahboob, E., Samad, MA., et al.[2022]

Empagliflozin, when administered to 15,081 patients with type 2 diabetes and moderate to severe chronic kidney disease (CKD), showed no new safety concerns, with similar rates of serious adverse events compared to placebo.

The treatment was associated with significantly lower risks of hyperkalemia and edema, suggesting potential benefits for patients with advanced CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Tuttle, KR., Levin, A., Nangaku, M., et al.[2022]

Empagliflozin effectively lowers blood sugar levels in patients with type 2 diabetes by inhibiting glucose reabsorption in the kidneys, resulting in an average reduction of HbA1c by approximately 0.8% without causing hypoglycemia, except in those already on insulin or sulphonylureas.

In addition to improving glycemic control, empagliflozin promotes weight loss (about 2 kg) and lowers blood pressure (systolic by approximately 4 mm Hg), while also providing cardiovascular protection, as demonstrated in the EMPA-REG OUTCOME trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[EMPAGLIFLOZIN (JARDIANCE) :Nw SGLT2 COTRANSPORTER INHIBITOR FOR TREATING TYPE 2 DIABETES]. Scheen, AJ.[2022]

In the EMPEROR-Reduced study involving over 3700 participants with chronic heart failure and reduced ejection fraction, empagliflozin significantly reduced the risk of hospitalization for heart failure complications (13.2% vs. 18.3% for placebo) over an average of 16 months.

Empagliflozin also showed a lower incidence of serious kidney problems (1.6% vs. 3.1% for placebo), indicating its potential safety and efficacy in managing heart failure, although it was associated with a higher rate of genital tract infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study. Zannad, F., Macari, S.[2023]

References

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

Finerenone in Predominantly Advanced CKD and Type 2 Diabetes With or Without Sodium-Glucose Cotransporter-2 Inhibitor Therapy. [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. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of finerenone in patients with chronic kidney disease and type 2 diabetes by GLP-1RA treatment: A subgroup analysis from the FIDELIO-DKD trial. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Gliflozins and finerenone: what are the prospects for their combination?] [2023]

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

Finerenone: First Approval. [2022]

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

Diabetes Drug Now Approved for Heart Failure. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The dual role of empagliflozin: Cardio renal protection in T2DM patients. [2022]

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

Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. [2022]

9. Belgium pubmed.ncbi.nlm.nih.gov

[EMPAGLIFLOZIN (JARDIANCE) :Nw SGLT2 COTRANSPORTER INHIBITOR FOR TREATING TYPE 2 DIABETES]. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study. [2023]

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

FINE-CKD model to evaluate economic value of finerenone in patients with chronic kidney disease and type 2 diabetes. [2022]

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

Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes by Sodium-Glucose Cotransporter 2 Inhibitor Treatment: The FIDELITY Analysis. [2023]