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Finerenone Plus Empagliflozin in CKD and T2D
NCT05254002Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2022
- Primary completion
- Mar 2025
- Countries
- 14
- Sponsor
- Bayer
- Modality
- Small Molecules
- Conditions
- chronic kidney disease (CKD)type 2 diabetes mellitus (T2DM)
01
Overview
Phase 2, randomised, double-blind trial of finerenone and empagliflozin in chronic kidney disease (CKD) and type 2 diabetes mellitus (T2DM) (3 arms), sponsored by Bayer. Primary endpoint: Urinary Albumin-to-Creatinine Ratio at 180 days. Started Jun 2022; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Finerenone and Empagliflozin
Finerenone (10 or 20 mg OD) + Empagliflozin (10 mg OD)
Finerenone and Empagliflozin placebo
Finerenone (10 or 20 mg OD) + Empagliflozin Placebo (OD)
Empagliflozin and Finerenone placebo
Empagliflozin (10 mg OD) + Finerenone Placebo (OD)
03
Who it enrols
Participants with CKD and T2D, treated with max tolerated ACEi or ARB, with eGFR 30-90 and UACR 100-5000, excluding those on SGLT2i or MRA, or with severe hepatic insufficiency or uncontrolled blood pressure.
04
Endpoints
Primary
Urinary Albumin-to-Creatinine Ratio
Secondary
Urinary Albumin-to-Creatinine Ratio
Estimated Glomerular Filtration Rate
Acute Kidney Injury Events
Hyperkalemia Events
Serum/Plasma Potassium
Symptomatic Hypotension Events
Genital Mycotic Events
Urosepsis and Pyelonephritis Events
05
Results
Primary endpoints met
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