Trial Tests Combination of Medications for Kidney Disease and Type 2 Diabetes

A Bayer clinical trial is seeking to evaluate the safety and efficacy of finerenone, which treats chronic kidney disease, alongside empagliflozin, a type 2 diabetes drug. This study could pave the way for an innovative combination therapy that is more convenient for people with diabetes.

Clinical Trials Identifier: NCT05254002

Trial Name: A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes  (CONFIDENCE)

Diabetes Type: Adults with type 2 diabetes

Trial Sponsor: Bayer 

What is the trial testing?

This study will enroll 807 participants with type 2 diabetes and chronic kidney disease to compare the safety and efficacy of combining finerenone and empagliflozin versus using each medicine separately. 

Participants will be randomly assigned to receive either:

1. Finerenone and empagliflozin

2. Finerenone and placebo

3. Empagliflozin and placebo

The primary goal of the study is to see if the combination therapy of finerenone and empagliflozin has better results on the kidney than either drug individually. To evaluate this, the level of protein in your urine (UACR) and kidney function will be measured.

Additionally, the study team will:

• collect blood and urine samples

• do a physical examination, including height and weight

• check your heart health by using an electrocardiogram (ECG)

• monitor your blood pressure

• ask questions about how you are feeling and any adverse events 

Why is this new trial important? 

Diabetes is one of the most common causes of chronic kidney disease (CKD) in adults, with around 1 in 3 people with diabetes also living with CKD. It is estimated that as many as 40% of people with diabetes may develop CKD during their lifetimes. To learn more about chronic kidney disease, read our article, Chronic Kidney Disease: The Hidden Complication.

Finerenone (brand name Kerendia) is a drug that was approved by the FDA in July 2021 to treat chronic kidney disease in people with type 2 diabetes. Empagliflozin (sold as Jardiance) is an SGLT-2 inhibitor that has been proven to lower blood glucose levels for people with diabetes. It also reduces the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure and reduces the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. Testing how these medications work together could lead to a more convenient option that combines both finerenone and empagliflozin.

Trial Length: 6 months

Trial Locations: This is a multicenter, worldwide study with 131 locations across the United States, Belgium, Canada, Germany, Japan, Italy, Spain, and Taiwan. See a list of all participating locations here.

Are you interested?

You may be eligible to participate in this trial if:

• You are 18 years or older with type 2 diabetes

• You have been diagnosed with chronic kidney disease

See a full list of inclusion/exclusion criteria here. 

For more information: To learn more, contact the Bayer study team at clinical-trials-contact@bayer.com or call 1-888-84 22937.

About the authors

Arvind Sommi

Arvind Sommi joined the diaTribe Foundation in 2021 after graduating with Phi Beta Kappa and honors from the University of Florida where he majored in Biology and minored in Sociology.... Read the full bio »