The goal of this study, performed entirely with computer programs, is to learn if using a combination of two drugs works better than using one alone, in the treatment of people with chronic kidney disease and type 2 diabetes mellitus.
The main questions it aims to answer are:
* How many events of heart failure, heart failure hospitalizations, and cardiovascular death happen in each group? * How do serious kidney problems progress in each of the groups?
Researchers will compare reference therapy (finerenone) with a combination of finerenone and empagliflozin.
There will not be human participants in this study. With the help of artificial intelligence, researchers will recreate a large population of people with chronic kidney disease and type 2 diabetes mellitus. Data on their disease, treatment, and laboratory parameters will be based on and simulated using real data from previous clinical trials conducted with real participants.
Patients with chronic kidney disease (eGFR 30-90 ml/min/1.73 m²)
Persistent albuminuria (UACR 100-5000 mg/g)
Type 2 diabetes mellitus (T2D) under stable blockade of the renin-angiotensin system (ACEi/ARB)
Participants with type 1 diabetes (T1D).
Participant with hepatic insufficiency classified as Child-Pugh C.
Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit.
Aeterna Medical Solutions SL
Lead sponsor
Bayer Hispania, S.L
Collaborator