Finerenone in Patients With Chronic Kidney Disease Due to Glomerular Diseases: A Randomized Clinical Trial.

Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, reduces the risk of kidney function loss in CKD, but its effects in individuals with CKD due to glomerular diseases are uncertain.

非甾体类盐皮质激素受体拮抗剂finerenone可以降低CKD患者肾功能丧失的风险，但在肾小球疾病引起的CKD患者中的效果尚不确定。

Background

To evaluate the efficacy and safety of finerenone in patients with glomerular diseases.

评估非奈利酮在肾小球疾病患者中的疗效和安全性。

DESIGN, SETTING, AND PARTICIPANTS: Prespecified exploratory subgroup analysis of a phase 3, randomized, double-blind, placebo-controlledtrial conducted across 24 countries and regions, focusing on participants with an investigator-reported glomerular disease diagnosis.

设计、设置和参与者：在24个国家和地区进行的第三阶段、随机、双盲、安慰剂对照试验的预定探索性亚组分析，重点是具有研究者报告的肾小球疾病诊断的参与者。

The overall trial enrolled adults with nondiabetic CKD and an estimated glomerular filtration rate (eGFR) of either (1) at least 25 to less than 60 mL/min/1.73 m2 and urinary albumin to creatinine ratio of at least 200 mg/g to less than 500 mg/g or (2) an eGFR of at least 25 to less than 90 mL/min/1.73 m2 and urinary albumin to creatinine ratio of at least 500 mg/g to less than 3500 mg/g.

整个试验招募了患有非糖尿病性慢性肾脏病(CKD)的成年人，其估算的肾小球滤过率(eGFR)为(1)至少25至小于60 mL/min/1.73 m2和尿白蛋白与肌酐比值至少200 mg/g至小于500 mg/g，或(2) eGFR至少25至小于90 mL/min/1.73 m2和尿白蛋白与肌酐比值至少500 mg/g至小于3500 mg/g。

intervention

Finerenone 10 mg or 20 mg taken orally once daily (n = 446) vs matching placebo (n = 457).

口服每日一次的非瑞酮10毫克或20毫克(n = 446)与匹配的安慰剂(n = 457)。

main_outcomes_and_measures

Annualized rate of eGFR decline (total eGFR slope) from baseline to month 32 (primary outcome of the main trial); percent change in albuminuria to 12 months; and a composite outcome of kidney failure or sustained 40% or more decline in eGFR (prespecified exploratory outcomes).

从基线到第32个月的估算肾小球滤过率（eGFR）年化下降率（总eGFR斜率）（主要试验的主要结果）；12个月时白蛋白尿的百分比变化；以及肾脏衰竭或eGFR持续下降40%或以上的复合结果（预先设定的探索性结果）。

Results

Of 1584 participants, 903 (57.0%) had investigator-reported glomerular disease, including 416 (46.1%) with immunoglobulin A nephropathy, 215 (23.8%) with focal segmental glomerulosclerosis, and 90 (10.0%) with membranous nephropathy.

在1584名参与者中，有903名（57.0%）被研究者报告有肾小球疾病，包括416名（46.1%）患有免疫球蛋白A肾病，215名（23.8%）患有局灶节段性肾小球硬化，以及90名（10.0%）患有膜性肾病。

Participants with glomerular disease (mean [SD] age, 51.1 [13.6] years; 362 female [40.1%]; 558 Asian [61.9%]) had a mean eGFR of 48.8 mL/min/1.73 m2 and median urinary albumin to creatinine ratio of 839.6 mg/g.

患有肾小球疾病的参与者（平均年龄[标准差]为51.1[13.6]岁；362名女性[40.1%]；558名亚洲人[61.9%]）的平均eGFR为48.8 mL/min/1.73 m2，中位尿白蛋白与肌酐比值为839.6 mg/g。

The total eGFR slope up to 32 months was -3.50 mL/min/1.73 m2 per year with finerenone and -4.23 mL/min/1.73 m2 per year with placebo (0.73 mL/min/1.73 m2 per year difference; 95% CI, 0.22-1.24).

在长达32个月的随访期内，使用finerenone的总eGFR斜率为每年-3.50 mL/min/1.73 m2，而使用安慰剂的为每年-4.23 mL/min/1.73 m2（差异为每年0.73 mL/min/1.73 m2；95%置信区间，0.22-1.24）。

Finerenone reduced albuminuria at month 12 by 42% (95% CI, 35%-48%) and lowered the risk of kidney failure or 40% or more eGFR decline (7.42 vs 9.60 events per 100 patient-years; hazard ratio, 0.74; 95% CI, 0.57-0.97).

在第12个月，芬瑞酮将白蛋白尿降低了42%（95%置信区间，35%-48%），并降低了肾功能衰竭或eGFR下降40%或更多的风险（每100患者年7.42比9.60事件；风险比，0.74；95%置信区间，0.57-0.97）。

conclusions_and_relevance

In this exploratory analysis, treatment with finerenone slowed kidney function decline, reduced albuminuria, and lowered the risk of kidney failure or substantial loss of kidney function in patients with glomerular diseases.

在这项探索性分析中，接受芬瑞酮治疗的患者减缓了肾功能下降，降低了白蛋白尿，并降低了肾功能衰竭或显著肾功能损失的风险，这些患者患有肾小球疾病。

These findings suggest an important role for finerenone in preserving kidney function in this population.

这些发现表明，非奈利酮在保护这一人群的肾功能方面发挥着重要作用。

trial_registration

ClinicalTrials.gov Identifier: NCT05047263.

ClinicalTrials.gov 注册号：NCT05047263。