BENITIONSClinical Trial Intelligence

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

Phase 2 Completed NCT05254002

ConditionType 2 Diabetes Mellitus, Chronic Kidney Disease
PhasePhase 2
SponsorBayer
StatusCompleted
Enrollment1,664 participants
InterventionsFinerenone (BAY94-8862 ) 10 mg, Empagliflozin, Empagliflozin Placebo, Finerenone (BAY94-8862 ) 20 mg, Finerenone Placebo
Start dateJun 23, 2022
Completion dateMar 14, 2025
Results postedJul 13, 2026

Summary

Finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD. Empagliflozin lowers blood sugar levels by increasing the excretion of glucose from the blood into the urine. In this study, the researchers want to learn how well the combination of finerenone and empagliflozin helps to slow down the worsening of the participants' kidney function compared to either treatment alone. For this, the level of protein in the urine will be measured. The investigators also want to know how safe the combination is compared to either treatment alone. Depending on the treatment group, the participants will either take the combination of finerenone and empagliflozin, or finerenone together with a placebo, or empagliflozin together with a placebo, once a day as tablets by mouth. A placebo looks like a treatment but does not have any medicine in it. Importantly, the participants will also continue to take their other current medicine for CKD and T2D. The participants will be in the study for up to 7.5 months and will ta

Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 180 Relative to Baseline in the Combination Therapy Group Versus Empagliflozin Alone

Baseline and Day 180 · ratio

Finerenone and Empagliflozin0.483 ratio
Empagliflozin and Finerenone Placebo0.708 ratio

Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 180 Relative to Baseline in the Combination Therapy Group Versus Finerenone Alone

Baseline and Day 180 · Ratio

Finerenone and Empagliflozin0.483 Ratio
Finerenone and Empagliflozin Placebo0.683 Ratio

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