研究设计和ALIGN的基线特征,ALIGN是阿特拉森坦在IgA脏病患者中的随机对照研究
Hiddo J L Heerspink1, Meg Jardine2, Donald E Kohan3
1Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Kidney international reports
|January 15, 2025
概括
作为内甲素A受体对抗剂的阿特拉森坦在IgA脏病 (IgAN) 的ALIGN试验中正在研究. 这项试验评估了其在高危患者中降低蛋白尿和保持功能的能力.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學.
- 药理学 药理学是指药理学的学科.
背景情况:
- 内甲素A (ETA) 受体的激活有助于IgA脏病 (IgAN) 的脏损伤.
- 阿特拉森坦是一种选择性的ETA受体对抗剂,对IGAN有潜在的治疗益处.
研究的目的:
- 评估阿特拉森坦在患有IgAN且患有功能丧失高风险的患者中的疗效和安全性.
- 评估阿特拉森坦对蛋白尿和功能保存的影响.
主要方法:
- ALIGN试验是一项3期,随机,双盲,安慰剂控制的研究.
- 接受Igan治疗的患者在132周内接受了阿特拉森坦或安慰剂.
- 主要结局:36周蛋白尿 (UPCR) 的变化;次要结局:eGFR变化,安全性和耐受性.
主要成果:
- 在20个国家,有404名患者被随机分配.
- 主层的基线特征:平均年龄为44.7岁,42.4%的女性,平均eGFR为58.9毫升/分钟/1.73米2,UPCR中位数为1.4g/g.
- 该试验包括一个主要层和一个探索性SGLT2i层.
结论:
- ALIGN试验调查了阿特拉森坦在全球Igan群体中的疗效和安全性.
- 它评估了阿特拉森坦在对RAS抑制剂反应不佳的患者中的作用.
- 一个探索臂检查了与SGLT2抑制剂结合的阿特拉森坦.
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