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)

STUDY OVERVIEW

This study sponsored by Bayer Pharmaceuticals aims to evaluate the effectiveness and safety of combining finerenone and empagliflozin in slowing the progression of kidney function decline in participants with chronic kidney disease (CKD) and type 2 diabetes (T2D) compared to either treatment alone. Participants will take either the combination of finerenone and empagliflozin, finerenone with a placebo, or empagliflozin with a placebo once daily for 6 months, alongside their regular CKD and T2D medications. The study will measure protein levels in urine to assess kidney function and include regular visits for blood and urine sample collection, vital signs monitoring, physical exams, ECGs, and tracking of adverse events over a total duration of up to 7.5 months.

STUDY GOALS

The goal of this study is to evaluate the effectiveness and safety of the combination of finerenone and empagliflozin in slowing the progression of kidney function decline in participants with chronic kidney disease and type 2 diabetes compared to either treatment alone.

LOCATION

El Paso, Texas: DaVita Clinical Research at DaVita Dialysis Centers

INCLUSION CRITERIA

  • Clinical diagnosis of chronic kidney disease (CKD) with:

    • Part A: eGFR 40-90 ml/min/1.73m² (no more than 20% with eGFR >75 ml/min/1.73m²) and historical eGFR <60 ml/min/1.73m² or registered CKD diagnosis.

    • Part B: eGFR 30-90 ml/min/1.73m² (no more than 20% with eGFR >75 ml/min/1.73m²) and historical eGFR <60 ml/min/1.73m² or registered CKD diagnosis.

    • UACR 100-5000 mg/g at screening (mean of 3 morning samples) and documented albuminuria/proteinuria in medical records.

  • Type 2 diabetes (T2D) with HbA1c <11% at screening.

  • Treated with the maximum tolerated dose of ACE inhibitor (ACEi) or angiotensin receptor blocker (ARB) for over 1 month at screening.

exclusion criteria

  • Type 1 diabetes (T1D).

  • Hepatic insufficiency (Child-Pugh C).

  • Blood pressure at Day 1 visit:

    • SBP >160 mmHg or DBP >100 mmHg.

    • SBP <90 mmHg.

  • Current treatment with SGLT2i or SGLT-1/2i that cannot be discontinued 8 weeks before screening and during the study.

  • Treatment with another mineralocorticoid receptor antagonist (MRA), renin inhibitor, potassium supplements, potassium sparing diuretic, potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) that cannot be discontinued 8 weeks before screening and during the study.

  • Treatment with Finerenone (Kerendia©) within 8 weeks before screening.

  • Serum/plasma potassium (K+) >4.8 mmol/L at screening.

For more information, visit ClinicalTrials.gov.