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
2期
已完成
NCT05254002
| 适应症 | Type 2 Diabetes Mellitus, Chronic Kidney Disease |
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| 分期 | 2期 |
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| 申办方 | Bayer |
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| 状态 | 已完成 |
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| 受试者人数 | 1,664 人 |
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| 干预(药物) | Finerenone (BAY94-8862 ) 10 mg, Empagliflozin, Empagliflozin Placebo, Finerenone (BAY94-8862 ) 20 mg, Finerenone Placebo |
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| 开始日期 | 2022年6月23日 |
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| 完成日期 | 2025年3月14日 |
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| 结果公布日 | 2026年7月13日 |
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摘要
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 Empagliflozin | 0.483 ratio |
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| Empagliflozin and Finerenone Placebo | 0.708 ratio |
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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 Empagliflozin | 0.483 Ratio |
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| Finerenone and Empagliflozin Placebo | 0.683 Ratio |
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