A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 5,734
- 主要终点
- The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death
研究概览
简要总结
The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ≥18 years of age
- •Type 2 diabetes mellitus (T2D) as defined by the American Diabetes Association
- •Diagnosis of chronic kidney disease (CKD) with at least one of the following criteria at run-in and screening visits:
- •persistent high albuminuria (UACR ≥30 to <300 mg/g in 2 out of 3 first morning void samples) and estimated glomerular filtration rate (eGFR) ≥25 but <60 mL/min/1.73 m² (CKD EPI) and presence of diabetic retinopathy or
- •persistent very high albuminuria (UACR ≥300 mg/g in 2 out of 3 first morning void samples) and eGFR ≥25 to <75 mL/min/1.73 m² (CKD-EPI)
- •Prior treatment with angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) as follows:
- •For at least 4 weeks prior to the run-in visit, subjects should be treated with either an ACEI or ARB, or both
- •Starting with the run-in visit, subjects should be treated with only an ACEI or ARB
- •For at least 4 weeks prior to the screening visit, subjects should be treated with the maximum tolerated labeled dose (but not below the minimal labeled dose) of only an ACEI or an ARB (not both) preferably without any adjustments to dose or choice of agent or to any other antihypertensive or antiglycemic treatment
- •Serum potassium ≤4.8 mmol/L at both the run-in and the screening visit
排除标准
- •Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis
- •Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg, sitting diastolic blood pressure (DBP) ≥110 mmHg at run-in visit, or mean sitting SBP ≥160 mmHg, sitting DBP ≥100 mmHg at screening)
- •Glycated hemoglobin (HbA1c) >12%
- •Mean SBP < 90 mmHg at the run-in visit or at the screening visit
- •Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association [NYHA] class II - IV) at run-in visit (class 1A recommendation for mineralcorticoid receptor antagonists [MRAs])
- •Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the screening visit
- •Dialysis for acute renal failure within 12 weeks of run-in visit
- •Renal allograft in place or scheduled within next 12 months from the run-in visit
研究组 & 干预措施
Finerenone (BAY94-8862)
Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
干预措施: Finerenone (BAY94-8862) (Drug)
Placebo
Participants received matching placebo once daily in addition to standard of care therapy
干预措施: Placebo (Drug)
结局指标
主要结局
The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death
时间窗: From randomization up until the first occurrence of the primary renal composite endpoint, or censoring at the end of the study, with an average follow-up time of 32 months
Count of participants and time from randomization to the first occurrence of the primary renal composite outcome, onset of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis.
次要结局
- The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease in eGFR of ≥57% From Baseline Over at Least 4 Weeks, or Renal Death(From randomization up until the first occurrence of the composite primary endpoint, or censoring at the end of the study, with an average of 32 months)
- All-cause Hospitalization(From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average of 32 months)
- Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline to Month 4(From baseline up until Month 4)
- The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hospitalization for Heart Failure(From randomization up until the first occurrence of the key secondary CV composite endpoint, or censoring at the end of the study, with an average of 32 months)
- All-cause Mortality(From randomization up until death due to any cause, or censoring at the end of the study visit, with an average of 32 months)