全球患者试验网络和CAPTIVATE平台临床试验设计:试验协议
Sradha S Kotwal1,2, Vlado Perkovic1,3, Meg J Jardine4,5,6
1Renal and Metabolic Division, The George Institute for Global Health, University of New South Wales, Sydney, Australia.
JAMA network open
|December 11, 2024
概括
全球患者试验网络 (GKPTN) 注册表和慢性病适应性平台试验研究各种治疗效果的治疗剂 (CAPTIVATE) 试验将加速慢性病 (CKD) 新疗法的发现. 这种适应性平台试验设计有效地测试了CKD患者的组合疗法.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學.
- 临床试验 临床试验
- 药物开发 药物开发
背景情况:
- 慢性病 (CKD) 影响全球近10亿人,需要新的治疗策略.
- 适应性平台试验提供了一种创新的方法,可以有效评估结合疗法,治疗诸如慢性病等复杂疾病.
研究的目的:
- 概述设计和提出全球患者试验网络 (GKPTN) 的基线发现.
- 描述慢性病适应性平台试验研究治疗效果的各种药剂 (CAPTIVATE) 试验的结构.
- 为患有脏疾病的个人确定新的治疗选择和治疗方法.
主要方法:
- GKPTN是一个正在进行的多中心注册表,于2020年5月启动,收集关于CKD患者特征,治疗方法和结果的数据.
- CAPTIVATE是一项3期,安慰剂控制,自适应平台随机临床试验,招募非透析性CKD患者,旨在从GKPTN站点招募患者.
- CAPTIVATE最初将研究一种矿物质皮质类受体抗剂,其主要结果集中在降低估计球过率 (eGFR) 下降的速度上.
主要成果:
- 目前,GKPTN已在8个国家的119个地点注册了4334名患者.
- 平均eGFR下降在具有较高基线eGFR和更严重的albuminuria的参与者中更为.
- 基线特征包括平均年龄为64.5岁,58.7%的女性参与者,糖尿病病是最常见的病因 (43.3%).
结论:
- GKPTN注册表和CAPTIVATE适应性平台试验具有很大的潜力,可以在CKD中推进治疗选择.
- 这种综合方法旨在优化病患者新疗法的开发和测试.
- 研究设计有助于对多种研究药物和组合进行有效的评估.
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