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

2상 완료 NCT05254002

대상 질환Type 2 Diabetes Mellitus, Chronic Kidney Disease
임상 단계2상
스폰서Bayer
상태완료
참여자 수1,664 명
중재(약물)Finerenone (BAY94-8862 ) 10 mg, Empagliflozin, Empagliflozin Placebo, Finerenone (BAY94-8862 ) 20 mg, Finerenone Placebo
시작일2022년 6월 23일
완료일2025년 3월 14일
결과 공개일2026년 7월 13일

요약

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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