III期 FIND-CKD 研究正式启动,非奈利酮临床研究扩展到非糖尿病肾病患者

2021-09-26 梅斯医学 梅斯医学

2021年9月20日,拜耳宣布启动 FIND-CKD 研究,这是一项多中心、随机、双盲、安慰剂对照的 III 期临床研究,考察在指南推荐疗法基础上加用非奈利酮治疗非糖尿病慢性肾病的疗效和安全性。

2021920日,拜耳宣布启动 FIND-CKD 研究,这是一项多中心、随机、双盲、安慰剂对照的 III 期临床研究,考察在指南推荐疗法基础上加用非奈利酮治疗非糖尿病慢性肾病的疗效和安全性。研究的主要目的是证明相较指南推荐疗法加用安慰剂,非奈利酮可以更有效地延缓这类患者的肾脏疾病进展。主要终点是从基线到第 32 个月患者肾功能随时间的平均变化率(估算的肾小球滤过率、eGFR 斜率)。

慢性肾脏病(CKD)是一种未被充分认识的常见致死性疾病,进展隐匿且不可预测,许多时候病情发展到晚期才出现症状。全球有8.4 亿人受到慢性肾病影响,美国1/3的成年人有患病风险,慢性肾病晚期患者可能需要透析或肾移植来维持生命。健康的肾脏充当身体的过滤器,清除血液中的废物,还控制体内水和电解质的含量,调节血压。随着肾功能下降,患者可能会出现一系列症状,包括腿部肿胀、白天疲倦、恶心、肌肉痉挛、关节疼痛、意识模糊、注意力不集中、记忆力问题等。 慢性肾病的主要危险因素包括糖尿病和高血压。

本项研究执行委员会联合主席,荷兰格罗宁根中心的Hiddo L. Heerspink教授说: “2017 年全球就有 120 万人死于慢性肾病,数字令人震惊。尽管全球来看糖尿病是慢性肾病的首要原因,但也有相当一部分肾病并非源自糖尿病,而是归因于诸如高血压等其他原因。临床亟需针对肾脏特异性疾病机制的新疗法。本项研究如果成功,将对全球慢性肾病患者具有重要意义。

非奈利酮是一种非甾体选择性盐皮质激素受体拮抗剂,在临床前研究中显示可阻断盐皮质激素受体过度激活导致的有害影响。 盐皮质激素受体过度激活被认为会导致慢性肾病进展和血管受损,这可能由代谢、血流动力学或炎症和纤维化因素驱动。在两项已完成的 III 期临床研究FIDELIO-DKD FIGARO-DKD中,非奈利酮已经被证明对慢性肾病合并2 型糖尿病患者的肾脏和心血管结局有益。

拜耳处方药事业部执行委员会成员,研发负责人Christian Rommel博士说:到目前为止,已经有13,000多名慢性肾病合并2 型糖尿病患者参加非奈利酮的III 期临床研究,结果表明:在标准疗法基础上,与安慰剂相比,非奈利酮对这类患者的肾脏和心血管结局有积极影响。新的 FIND-CKD 研究将非奈利酮的临床研究扩展到非糖尿病人群,这个群体亟需延缓疾病进展的新疗法。

III FIND-CKD研究将招募1500 多名非糖尿病慢性肾病患者,病因包括高血压和慢性肾小球肾炎(肾脏炎症),在标准疗法基础上,比较非奈利酮与安慰剂的效果。在个体耐受最大剂量的肾素-血管紧张素系统阻断疗法的基础上,例如血管紧张素转换酶抑制剂或血管紧张素 II 受体阻断剂,患者将随机接受非奈利酮10mg20mg 或安慰剂。

今年7月,依据III期临床FIDELIO-DKD研究在慢性肾病合并2型糖尿病患者中的阳性结果,非奈利酮在美国获得上市批准。非奈利酮已经在欧盟和中国等多个国家或地区递交了上市申请,正处于审评阶段。

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    2022-07-20 juliusluan78
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    2021-09-28 xiaogang319
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    2021-09-26 14775a26m11暂无昵称

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    2021-09-26 ms4000002024020416

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