Abstract：
OBJECTIVE: Finerenone, a non-steroidal mineralocorticoid receptor antagonist, improved kidney, and cardiovascular outcomes in patients with CKD and T2D in two Phase 3 outcome trials. The FIND-CKD study investigates the effect of finerenone in adults with CKD without diabetes.
METHODS: FIND-CKD (NCT05047263 and EU CT 2023-506897-11-00) is a randomized, double-blind, placebo-controlled Phase 3 trial in patients with CKD of non-diabetic aetiology. Adults with a urinary albumin-creatinine ratio (UACR) of ≥ 200 to ≤3500 mg/g and eGFR ≥ 25 to <90 mL/min/1.73 m2 receiving a maximum tolerated dose of a renin-angiotensin-system (RAS) inhibitor were randomized 1:1 to once daily placebo or finerenone 10 or 20 mg depending on eGFR above or below 60 mL/min/1.73 m2. The primary efficacy outcome is total eGFR slope, defined as the mean annual rate of change in eGFR from baseline to Month 32. Secondary efficacy outcomes include a combined cardiorenal composite outcome comprising time to kidney failure, sustained ≥57% decrease in eGFR, hospitalization for heart failure, or cardiovascular death, as well as separate kidney and cardiovascular composite outcomes. Adverse events are recorded to assess tolerability and safety.
RESULTS: Across 24 countries, 3231 patients were screened and 1584 were randomized to study treatment. The most common causes of CKD were chronic glomerulonephritis (57.0%) and hypertensive/ischaemic nephropathy (29.0%). Immunoglobulin A nephropathy was the most common glomerulonephritis (26.3% of the total population). At baseline, mean eGFR and median UACR were 46.7 mL/min/1.73 m2 and 818.9 mg/g, respectively. Diuretics were used by 282 participants (17.8%), statins by 851 (53.7%), and calcium channel blockers by 794 (50.1%). SGLT2 inhibitors were used in 16.9% of patients; these individuals had a similar mean eGFR (45.6 vs 46.8 mL/min/1.73 m2) and slightly higher median UACR (871.9 vs 808.3 mg/g) compared to those not using SGLT2 inhibitors at baseline.
CONCLUSIONS: FIND-CKD is the first Phase 3 trial of finerenone in patients with CKD of non-diabetic aetiology.
METHODS: FIND-CKD (NCT05047263 and EU CT 2023-506897-11-00) is a randomized, double-blind, placebo-controlled Phase 3 trial in patients with CKD of non-diabetic aetiology. Adults with a urinary albumin-creatinine ratio (UACR) of ≥ 200 to ≤3500 mg/g and eGFR ≥ 25 to <90 mL/min/1.73 m2 receiving a maximum tolerated dose of a renin-angiotensin-system (RAS) inhibitor were randomized 1:1 to once daily placebo or finerenone 10 or 20 mg depending on eGFR above or below 60 mL/min/1.73 m2. The primary efficacy outcome is total eGFR slope, defined as the mean annual rate of change in eGFR from baseline to Month 32. Secondary efficacy outcomes include a combined cardiorenal composite outcome comprising time to kidney failure, sustained ≥57% decrease in eGFR, hospitalization for heart failure, or cardiovascular death, as well as separate kidney and cardiovascular composite outcomes. Adverse events are recorded to assess tolerability and safety.
RESULTS: Across 24 countries, 3231 patients were screened and 1584 were randomized to study treatment. The most common causes of CKD were chronic glomerulonephritis (57.0%) and hypertensive/ischaemic nephropathy (29.0%). Immunoglobulin A nephropathy was the most common glomerulonephritis (26.3% of the total population). At baseline, mean eGFR and median UACR were 46.7 mL/min/1.73 m2 and 818.9 mg/g, respectively. Diuretics were used by 282 participants (17.8%), statins by 851 (53.7%), and calcium channel blockers by 794 (50.1%). SGLT2 inhibitors were used in 16.9% of patients; these individuals had a similar mean eGFR (45.6 vs 46.8 mL/min/1.73 m2) and slightly higher median UACR (871.9 vs 808.3 mg/g) compared to those not using SGLT2 inhibitors at baseline.
CONCLUSIONS: FIND-CKD is the first Phase 3 trial of finerenone in patients with CKD of non-diabetic aetiology.
摘要：
目标：Finerenone，非甾体盐皮质激素受体拮抗剂，改善肾脏，在两项3期结局试验中，CKD和T2D患者的心血管结局。FIND-CKD研究调查了在无糖尿病的CKD成人中芬酮的作用。
方法：FIND-CKD（NCT05047263和EUCT2023-506897-11-00）是随机的，双盲,非糖尿病病因CKD患者的安慰剂对照3期试验。尿白蛋白-肌酐比率（UACR）≥200至≤3500mg/g且eGFR≥25至<90mL/min/1.73m2的成年人接受最大耐受剂量的肾素-血管紧张素系统（RAS）抑制剂，根据eGFR高于或低于60mL/min/1.73m2，随机分为1：1至每天一次安慰剂或finerenone10或20mg。主要疗效结果是总eGFR斜率，定义为eGFR从基线到第32个月的平均年变化率。次要疗效结果包括合并的心肾复合结果，包括肾衰竭时间，eGFR持续下降≥57%，心力衰竭住院治疗,或心血管死亡，以及单独的肾脏和心血管综合结局。记录不良事件以评估耐受性和安全性。
结果：在24个国家/地区，筛选了3231名患者，并随机分配了1584名患者进行研究治疗。CKD的最常见原因是慢性肾小球肾炎（57.0％）和高血压/缺血性肾病（29.0％）。免疫球蛋白A肾病是最常见的肾小球肾炎（占总人口的26.3％）。在基线,平均eGFR和中位数UACR分别为46.7mL/min/1.73m2和818.9mg/g，分别。282名参与者（17.8%）使用利尿剂，他汀类药物增长851（53.7%），和钙通道阻滞剂794（50.1%）。SGLT2抑制剂在16.9％的患者中使用;与基线时不使用SGLT2抑制剂的患者相比，这些个体具有相似的平均eGFR（45.6vs46.8mL/min/1.73m2）和稍高的中位数UACR（871.9vs808.3mg/g）。
结论：FIND-CKD是Finerenone在非糖尿病病因CKD患者中的第一个3期试验。
方法：FIND-CKD（NCT05047263和EUCT2023-506897-11-00）是随机的，双盲,非糖尿病病因CKD患者的安慰剂对照3期试验。尿白蛋白-肌酐比率（UACR）≥200至≤3500mg/g且eGFR≥25至<90mL/min/1.73m2的成年人接受最大耐受剂量的肾素-血管紧张素系统（RAS）抑制剂，根据eGFR高于或低于60mL/min/1.73m2，随机分为1：1至每天一次安慰剂或finerenone10或20mg。主要疗效结果是总eGFR斜率，定义为eGFR从基线到第32个月的平均年变化率。次要疗效结果包括合并的心肾复合结果，包括肾衰竭时间，eGFR持续下降≥57%，心力衰竭住院治疗,或心血管死亡，以及单独的肾脏和心血管综合结局。记录不良事件以评估耐受性和安全性。
结果：在24个国家/地区，筛选了3231名患者，并随机分配了1584名患者进行研究治疗。CKD的最常见原因是慢性肾小球肾炎（57.0％）和高血压/缺血性肾病（29.0％）。免疫球蛋白A肾病是最常见的肾小球肾炎（占总人口的26.3％）。在基线,平均eGFR和中位数UACR分别为46.7mL/min/1.73m2和818.9mg/g，分别。282名参与者（17.8%）使用利尿剂，他汀类药物增长851（53.7%），和钙通道阻滞剂794（50.1%）。SGLT2抑制剂在16.9％的患者中使用;与基线时不使用SGLT2抑制剂的患者相比，这些个体具有相似的平均eGFR（45.6vs46.8mL/min/1.73m2）和稍高的中位数UACR（871.9vs808.3mg/g）。
结论：FIND-CKD是Finerenone在非糖尿病病因CKD患者中的第一个3期试验。
