方法 文章研究协议:研究设计和基线特征用于慢性病中阿尔多氨酸合成酶抑制的慢性病
Katherine R Tuttle1, Peter Rossing2, Sibylle J Hauske3,4
1Division of Nephrology, Department of Medicine, University of Washington, Spokane, Washington, USA.
American journal of nephrology
|October 30, 2023
概括
这项II期研究研究了BI 690517,一种阿尔多素合成酶抑制剂,用于慢性病 (CKD). 结果将指导未来的开发,用于在CKD患者中潜在的添加性脏保护.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學.
- 心血管医学 心血管医学
- 药理学 药理学是指药理学的学科.
背景情况:
- 阿尔多氨酸合成酶 (AS) 抑制提供了一种潜在的策略来控制阿尔多氨酸水平升高,特别是在接受氨酸 - 血管新生素系统 (RAS) 抑制的患者中.
- BI 690517是一种正在研究的AS抑制剂,正在评估其在治疗慢性病 (CKD) 的有效性和安全性.
研究的目的:
- 评估每日口服BI 690517在患有CKD的参与者的疗效和安全性.
- 确定BI 690517在患者中具有或没有empagliflozin的潜在附加性脏保护,这些患者已经服用RAS抑制剂.
主要方法:
- 一个跨国,II期,双盲,随机对照试验 (NCT05182840) 涉及714名患有CKD的成年人.
- 参与者接受了使用empagliflozin或安慰剂的背景治疗,随后接受了14周的BI 690517 (3 mg,10 mg或20 mg) 或安慰剂治疗期.
- 主要终点是尿中白蛋白与肌素比率 (UACR) 与基线在第14周的变化.
主要成果:
- 该研究招募了714名患有CKD的成年人,主要是男性 (66.6%),平均年龄为63.8岁.
- 很大一部分参与者 (70.6%) 患有2型糖尿病.
- 基线特征包括平均eGFR为51.9mL/min/1.73m2和UACR中位数为426.3mg/g.
结论:
- 这项研究旨在为BI 690517的后续临床试验提供剂量选择信息.
- 这些发现将有助于确定BI 690517是否提供了有利的安全概况,并有可能在使用RAS抑制剂的CKD患者中增强脏保护.
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