2023-506981-30-00已完成2 期
(21839) A parallel-group treatment, Phase 2, double-blind, three-arm study to assess efficacy and safety of finerenone plus empagliflozin compared with either finerenone or empagliflozin in participants with chronic kidney disease and type 2 diabetes.
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer AG
- 入组人数
- 220
- 试验地点
- 57
- 主要终点
- Mean ratio of change from baseline to Day 180 in Urinary albumin to creatinine ratio (UACR) for the combination therapy group, to empagliflozin alone.
研究概览
简要总结
To demonstrate that combination therapy using finerenone and empagliflozin is superior in reducing UACR (Urinary albumin to-creatinine ratio) than either empagliflozin or finerenone alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Overall Study (overall period)
- 盲法
- Double (Investigator, Subject, Carer, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participant with a clinical diagnosis of chronic kidney disease (CKD) and the following: a. In Part A: eGFR 40-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnosis of CKD. b. In Part B: eGFR 30-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnostic of CKD. c. 100 ≤UACR <5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant's medical records at least 3 months prior to screening
- •Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening <11%.
- •Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit.
排除标准
- •Participants with type 1 diabetes (T1D).
- •Participant with hepatic insufficiency classified as Child-Pugh C.
- •Participant with blood pressure at Day 1 visit (Visit 2) higher than 160 SBP or 100 DBP or SBP lower than 90 mmHg.
- •Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
- •Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
- •Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit.
- •Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening (central laboratory value).
结局指标
主要结局
Mean ratio of change from baseline to Day 180 in Urinary albumin to creatinine ratio (UACR) for the combination therapy group, to empagliflozin alone.
Mean ratio of change from baseline to Day 180 in Urinary albumin to creatinine ratio (UACR) for the combination therapy group, to empagliflozin alone.
Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone.
Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone.
次要结局
- Proportion of participants with urosepsis and pyelonephritis events.
- Total number of urosepsis and pyelonephritis events.
- Relative change in UACR between end of treatment visit and 30 days after end of treatment visit.
- Relative change in UACR between 30 days after end of treatment visit and baseline.
- Relative change in UACR category (>30%, >40%, >50%) at 180 days.
- Ratio of change from baseline in eGFR at 30 days.
- eGFR decline greater than 30% at 30 days from baseline.
- Ratio of change in eGFR at 180 days and 210 days from day 30.
- Proportion of participants with of AKI events.
- Total number of AKI events.
- Number of participants with hyperkalemia events (moderate hyperkalemia [5.5 6.0 mmol/L])
- Total number of hyperkalemia events (moderate hyperkalemia [5.5 6.0 mmol/L])
- Change from baseline in K+
- Proportion of participants with severe hypoglycemia events.
- Total number of events of severe hypoglycemia events.
- Proportion of participants with symptomatic hypotension events.
- Total number of symptomatic hypotension events.
- Proportion of participants with genital mycotic events.
- Total number of genital mycotic events.
- Proportion of participants with ketoacidosis events.
- Total number of ketoacidosis events.
- Proportion of participants with necrotizing fasciitis of the perineum events.
- Total number of necrotizing fasciitis of the perineum events.
研究者
Therapeutic Area Head
Scientific
Bayer AG
研究点 (57)
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