EASi-KIDNEY - Studies of Heart & Kidney Protection with BI 690517 in combination with empagliflozin: A multicenter, international, randomized, double-blind, placebo-controlled clinical trial of the aldosterone synthase inhibitor BI 690517 in combination with empagliflozin in patients with chronic kidney disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,650
- 试验地点
- 121
- 主要终点
- Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression (defined as kidney failure or a sustained decline of ≥40% in eGFR from randomization); or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death.
研究概览
简要总结
Whether taking a BI 690517 pill once a day compared to an inactive pill (placebo), in combination with an empagliflozin pill, prevents worsening of kidney disease, hospitalisation for heart failure, or death from heart disease in people with kidney disease.
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomized
- 盲法
- Double (Investigator, Monitor, Analyst, Subject)
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
- 否
入选标准
- •Age >= 18 years at Screening
- •Evidence of CKD at risk of kidney disease progression is defined on the basis of local laboratory results recorded at least 3 months before and at the time of the Screening visit, and requires: (a) CKD-EPI eGFR ≥20 <45 mL/min/1.73m²; or (b) CKD-EPI eGFR ≥45 <90 mL/min/1.73m² with uACR ≥200 mg/g (or protein-to-creatinine ratio ≥300 mg/g).
排除标准
- •Blood potassium of >5.2 mmol/L at Screening visit
- •Blood ALT or AST >3x ULN at Screening visit
- •Known liver cirrhosis
- •On dialysis, functioning kidney transplant, or scheduled living donor transplant
- •Treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days
- •Receiving more than one RAS inhibitor (i.e. on dual therapy with two of an ACEi, ARB or direct renin inhibitor)
- •Currently treated with an MRA (e.g. spironolactone, eplerenone, finerenone)
- •Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone)
- •Further exclusion criteria (see protocol)
研究组 & 干预措施
Jardiance 10 mg film-coated tablets, EMPAGLIFLOZIN
干预措施: Jardiance 10 mg film-coated tablets (Drug)
Placebo tablet matching BI690517
干预措施: Placebo tablet matching BI690517 (Drug)
BI 690517
干预措施: BI 690517 (Drug)
Jardiance 10 mg film-coated tablets, EMPAGLIFLOZIN
干预措施: EMPAGLIFLOZIN (Drug)
结局指标
主要结局
Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression (defined as kidney failure or a sustained decline of ≥40% in eGFR from randomization); or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death.
Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression (defined as kidney failure or a sustained decline of ≥40% in eGFR from randomization); or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death.
次要结局
- Annual rate of change in eGFR from 3 months until last scheduled visit (i.e. chronic eGFR slope)
- Time to first event of kidney failure, hospitalization for heart failure or cardiovascular death
- Time to kidney disease progression
- Occurrences of hospitalizations for heart failure (first and any subsequent, combined) or cardiovascular death
- Occurrences of hospitalizations from any cause (first and any subsequent, combined)
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH