Finerenone + Empagliflozin for Chronic Kidney Disease and Type 2 Diabetes
(CONFIDENCE Trial)

Recruiting in Palo Alto (17 mi)

+258 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bayer

No Placebo Group

Prior Safety Data

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.

Research Team

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%.

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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.

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Treatment Details

Interventions

Empagliflozin (SGLT2 Inhibitor)
Finerenone (Mineralocorticoid Receptor Antagonist)

Trial OverviewThe 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

3Treatment groups

Experimental Treatment

Group I: Finerenone and Empagliflozin placeboExperimental Treatment3 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 EmpagliflozinExperimental Treatment3 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 placeboExperimental Treatment2 Interventions

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

Empagliflozin is already approved in Canada, Japan for the following indications: