Finerenone in Type 1 Diabetes and Chronic Kidney Disease.

The efficacy and safety of finerenone in persons with type 1 diabetes and CKD are unknown.

finerenone在1型糖尿病和CKD患者中的疗效和安全性尚不清楚。

Methods

We conducted a phase 3 trial involving adults who had type 1 diabetes, CKD (estimated glomerular filtration rate [eGFR], 25 to <90 ml per minute per 1.73 m2 of body-surface area), and albuminuria (urinary albumin-to-creatinine ratio [with albumin measured in milligrams and creatinine measured in grams], 200 to <5000) and were receiving an angiotensin-converting-enzyme (ACE) inhibitor or an angiotensin-receptor blocker.

我们进行了一项涉及成人的III期临床试验，这些成人患有1型糖尿病、慢性肾脏病（估算的肾小球滤过率[eGFR]为25至<90毫升/分钟/1.73平方米体表面积）和白蛋白尿（尿白蛋白与肌酐比值[白蛋白以毫克计，肌酐以克计]为200至<5000），并且正在接受血管紧张素转换酶(ACE)抑制剂或血管紧张素受体阻滞剂治疗。

Participants were randomly assigned to receive finerenone (10 or 20 mg per day, depending on the eGFR) or matching placebo.

参与者被随机分配接受finerenone（每天10或20毫克，根据eGFR而定）或匹配的安慰剂。

The primary outcome was the relative change in the urinary albumin-to-creatinine ratio over a period of 6 months.

主要结果是6个月内尿液白蛋白与肌酐比值的相对变化。

Results

A total of 242 participants underwent randomization.

共有242名参与者进行了随机分组。

The median urinary albumin-to-creatinine ratio decreased from 574.6 at baseline to 373.5 at 6 months among all the participants assigned to receive finerenone and from 506.4 to 475.6 among those assigned to receive placebo.

在所有被分配接受finerenone的参与者中，基线时的中位尿白蛋白/肌酐比值从574.6降低到6个月时的373.5，而在被分配接受安慰剂的参与者中，该比值从506.4降低到475.6。

Over a period of 6 months, the urinary albumin-to-creatinine ratio decreased by 34% with finerenone (geometric mean ratio to baseline, 0.66; 95% confidence interval[CI], 0.60 to 0.73) and 12% with placebo (geometric mean ratio to baseline, 0.88; 95% CI, 0.79 to 0.98), which corresponded to a 25% greater reduction with finerenone than with placebo (geometric mean ratio for finerenone vs. placebo, 0.75; 95% CI, 0.65 to 0.87; P<0.001).

在6个月的时间内，接受finerenone治疗的患者的尿白蛋白/肌酐比值下降了34%（与基线的几何平均比值为0.66；95%置信区间[CI]为0.60至0.73），而接受安慰剂治疗的患者下降了12%（与基线的几何平均比值为0.88；95% CI为0.79至0.98），这相当于finerenone比安慰剂多降低了25%（finerenone与安慰剂的几何平均比值为0.75；95% CI为0.65至0.87；P<0.001）。

The most common adverse eventwas hyperkalemia (in 12 participants [10.1%] with finerenone and in 4 [3.3%] with placebo); 2 participants (1.7%) discontinued finerenone because of hyperkalemia.

最常见的不良事件是高钾血症（在12名接受finerenone治疗的参与者中[10.1%]，以及在4名[3.3%]接受安慰剂治疗的参与者中出现；有2名参与者[1.7%]因高钾血症停用finerenone。

At 6 months, the change in the eGFR was -5.6 ml per minute per 1.73 m2 with finerenone and -2.7 ml per minute per 1.73 m2 with placebo (difference, -2.9 ml per minute per 1.73 m2; 95% CI, -5.1 to -0.7); eGFR values approached baseline levels during the washout period.

在6个月时，finerenone组的eGFR变化为每分钟每1.73平方米减少5.6毫升，而安慰剂组为每分钟每1.73平方米减少2.7毫升（差异为每分钟每1.73平方米减少2.9毫升；95%置信区间为-5.1至-0.7）；在洗脱期期间，eGFR值接近基线水平。

Conclusions

In adults with type 1 diabetes and CKD, finerenone resulted in a significantly greater decrease in the urinary albumin-to-creatinine ratio than placebo.

在患有1型糖尿病和慢性肾脏病（CKD）的成人中，非奈利酮相较于安慰剂，导致尿白蛋白与肌酐比值显著降低。

(Funded by Bayer; FINE-ONE ClinicalTrials.gov number, NCT05901831.).

(该研究由拜耳资助；FINE-ONE 临床试验注册号为NCT05901831。)