Trial Seeking People With Chronic Kidney Disease and Type 2 Diabetes
A clinical trial is recruiting participants with type 2 diabetes and chronic kidney disease (CKD) to see how well a combination of glucose-lowering and kidney-protective drugs works to slow the progression of CKD. See if you are eligible.
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 trial is investigating the impact of a combination of drugs – empagliflozin (brand name Jardiance) and finerenone (Kerendia) – on slowing the progression of chronic kidney disease in people with type 2 diabetes. Participants will be assigned to one of three groups; one group will receive both drugs, while the other two will receive either empagliflozin and a placebo, or finerenone and a placebo.
The study will last approximately 7.5 months, and researchers plan to enroll 807 participants. Researchers will track changes in kidney function, as measured by UACR and eGFR, comparing average results among the three groups in the study. Participants will need to visit a trial site in-person seven times throughout the study.
Why is this important?
SGLT-2 inhibitors, such as empagliflozin, have been a highly effective treatment option for many people with type 2 diabetes, not only to manage glucose, but to protect against kidney disease and heart failure. Finerenone, a different type of drug called a non-steroidal mineralocorticoid receptor antagonist (or MRA), has also been shown to protect against kidney failure and eGFR decline.
With this trial, researchers hope to understand whether the drugs, when used together, could potentially have a greater effect on protecting against chronic kidney disease in people with type 2 diabetes.
Are you interested?
You may be eligible to participate if:
You are 18 years or older and have been diagnosed with type 2 diabetes and chronic kidney disease
*CKD is monitored using two lab tests – eGFR and UACR. This trial is specifically looking for people with a UACR above 300, but less than 5000. For more about understanding your kidney screening results, see Recently Screened for Kidney Disease? Now What?
You have an A1C of less than 11%
You have NOT had diabetic ketoacidosis (DKA) in the past 5 years
You are NOT taking any other SGLT-2 inhibitor
**Note: Those currently taking an SGLT-2 inhibitor can still participate, but must stop taking the drug at least 8 weeks before screening for the trial. Be sure to talk to your healthcare provider before making any changes to your medications.
See a full list of inclusion/exclusion criteria here.