Finerenone + Empagliflozin for Chronic Kidney Disease and Type 2 Diabetes

(CONFIDENCE Trial)

No longer recruiting at 292 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining finerenone and empagliflozin can more effectively slow kidney damage in individuals with chronic kidney disease (CKD) and type 2 diabetes (T2D) compared to each drug alone. Researchers seek to understand how this combination affects protein levels in urine and assess its safety. Participants will receive either the drug combination or one of the drugs with a placebo, while continuing their usual CKD and T2D medications. This trial may suit those diagnosed with CKD and type 2 diabetes who have been on a stable dose of either ACE inhibitors or ARBs, but not both, for over a month. As a Phase 2 trial, it focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that finerenone is generally safe for people with chronic kidney disease (CKD) and type 2 diabetes. In studies, it reduced the risk of kidney and heart problems without introducing new safety issues compared to a placebo.

Empagliflozin has also undergone safety testing in people with type 2 diabetes and CKD. It did not raise new safety concerns and even provided some health benefits. Although some patients experienced kidney issues requiring hospital care, such cases were uncommon. Doctors will monitor this closely.

Both treatments have been tested separately and found safe. However, using them together is new. This study aims to assess their safety in combination. Participants will be closely monitored for any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine two promising drugs, Finerenone and Empagliflozin, which offer a fresh approach to managing chronic kidney disease in people with type 2 diabetes. Most treatments for these conditions focus on controlling blood sugar levels or blood pressure. However, Finerenone is a non-steroidal mineralocorticoid receptor antagonist that reduces inflammation and fibrosis in the kidneys, while Empagliflozin is an SGLT2 inhibitor that helps the kidneys remove glucose from the bloodstream, also reducing the risk of heart failure. Together, they target different pathways, potentially providing enhanced protection for the kidneys and offering a new way to tackle the disease progression more effectively.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease and type 2 diabetes?

Research shows that finerenone can lower the risk of worsening kidney disease and heart problems in people with chronic kidney disease (CKD) and type 2 diabetes (T2D). Empagliflozin has slowed kidney disease and reduced the risk of kidney failure or death from heart issues. In this trial, one group of participants will receive both finerenone and empagliflozin. Previous studies suggest this combination may reduce protein in urine more effectively than when used alone. Lower protein levels in urine indicate better kidney health. Overall, using both medications together might slow kidney damage more effectively in patients with CKD and T2D. Other participants will receive either finerenone with a placebo for empagliflozin or empagliflozin with a placebo for finerenone. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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]

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, 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 (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]

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]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2204233

Empagliflozin in Patients with Chronic Kidney Disease Empagliflozin therapy led to a lower risk of progression of kidney disease or death from cardiovascular causes than placebo.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7615591/

Effects of Empagliflozin on Progression of Chronic Kidney ... Empagliflozin slowed the rate of progression of CKD among all types of participant in the EMPA-KIDNEY trial, including those with little albuminuria.

3. thelancet.com thelancet.com/journals/landia/article/PIIS2213-8587(25)00222-0/fulltext

an individual participant-level meta-analysis The risk of kidney failure was reduced by 34%. Benefits were evident irrespective of the predicted size of the acute dip in eGFR and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9210861/

Safety of Empagliflozin in Patients With Type 2 Diabetes ... Use of empagliflozin in patients with type 2 diabetes and advanced CKD raised no new safety concerns and may have beneficial effects on the development of ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025002706

Effects of empagliflozin on quality of life and healthcare use ... Our findings indicate that empagliflozin reduced ESKD costs in all categories of patients with CKD regardless of diabetes status, level of albuminuria or kidney ...

6. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.117.028268

Empagliflozin and Clinical Outcomes in Patients With Type ... Conclusions: Empagliflozin improved clinical outcomes and reduced mortality in vulnerable patients with type 2 diabetes mellitus, established ...

7. pro.boehringer-ingelheim.com pro.boehringer-ingelheim.com/us/payor/vital-perspectives/jardiance/clinical/guidelines/ckd

Guidelines - Chronic Kidney Disease | Jardiance Clinical Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors, including JARDIANCE.

8. mdpi.com mdpi.com/1999-4923/15/10/2394

Comparative Safety Analysis of Empagliflozin in Type 2 ... Conclusions: The usage of empagliflozin in diabetic CKD patients shows a significant reduction in many adverse outcomes compared to sitagliptin, ...