第三代非甾体MR拮抗剂finerenone对慢性心力衰竭和糖尿病性肾病进入III期临床试验阶段

2015-09-01 佚名 不详

德国制药巨头拜耳(Bayer)近日宣布,将启动新型口服非甾体盐皮质激素受体拮抗剂(MRA)finerenone(BAY 94-8862)的III期临床开发项目,计划开展3个III期临床研究,调查finerenone治疗慢性心脏衰竭(CHF)和糖尿病性肾病(DKC)的疗效和安全性。首批患者预计将在2015年底招募。此次III期项目的启动,是基于在CHF和DKD中开展的4个剂量探索研究。 近年来,尽

德国制药巨头拜耳(Bayer)近日宣布,将启动新型口服非甾体盐皮质激素受体拮抗剂(MRA)finerenone(BAY 94-8862)的III期临床开发项目,计划开展3个III期临床研究,调查finerenone治疗慢性心脏衰竭(CHF)和糖尿病性肾病(DKC)的疗效和安全性。首批患者预计将在2015年底招募。此次III期项目的启动,是基于在CHF和DKD中开展的4个剂量探索研究。

近年来,尽管已取得实质性进展,但慢性心脏衰竭(CHF)仍是一种致命性疾病,5年生存率与晚期癌症类似。而糖尿病性肾病(DKD)是一种常见的糖尿病并发症,也是西方国家终末期肾脏疾病(ESRD)的最常见病因,据估计,由糖尿病导致的新诊ESRD病例超过40%。

慢性心脏衰竭(CHF)方面,拜耳将开展一项III期FINESSE-HF研究,该研究的启动是基于探索性IIb期ARTS-HF研究的积极数据,该研究的数据已于近日提交至在英国伦敦举行的2015年欧洲心脏病学会年会(ESC2015)。FINESSE-HF研究将在35个国家(包括欧洲、日本、中国及美国等)超过3600例低射血分数(HFrEF)并伴有2型糖尿病和/或慢性肾脏病的慢性心脏衰竭(CHF)患者中开展。

糖尿病性肾病(DKD)方面,拜耳将开展2个III期研究(FIGARO-DKD和FIDELIO-DKD),这些研究的启动是基于IIb期ARTS-DN研究的积极数据,相关数据已于今年3月提交至2015世界肾脏病大会(WCN)。FIGARO-DKD将在6400例临床确诊糖尿病性肾脏病(DKD)的高尿蛋白(尿白蛋白/肌醉比率: 30mg/g<UACR<300mg/g)患者中开展,FIDELIO-DKD将在4800例临床确诊DKD的极高尿蛋白(UACR≥300mg/g)患者中开展,将调查finerenone相对于安慰剂的疗效和安全性。

finerenone(BAY 94-8862)是新一代口服、非甾体盐皮质激素受体拮抗剂(MRA),能够阻断醛甾酮(aldosterone)导致的盐皮质激素受体(MR)过度激活产生的有害影响。MR的过度激活可在心脏和肾脏中导致病理性改变,而这可通过有效的MR阻断加以预防。当前可用的甾体类MRA已被证明能够有效降低伴有低射血分数(HFrEF)的心脏衰竭(HF)患者的心血管死亡率,但严重的副作用(高钾血症、肾功能不全、抗雄激素/孕激素)限制了这类药物的使用。

finerenone是第三代MRA,在临床前、I期、II期临床研究中已展现出更好的疗效和安全性。目前,该药正开发用于慢性心脏衰竭及糖尿病性肾病的治疗。

原始出处:

Bayer Expands Finerenone Clinical Development Programme with Three Phase III Studies in Patients with Chronic Heart Failure and Patients with Diabetic Kidney Disease

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    2022-09-20 小小医者

    #Finerenone#对慢性#心力衰竭##糖尿病性肾病#,又是一代新药

    0

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    2016-06-30 juliusluan78
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  4. 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  5. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57357, encodeId=629f5e3572c, content=嗯,不错,, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:14:00 CST 2016, time=2016-01-14, status=1, ipAttribution=)]
  6. 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  7. 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04:23:00 CST 2015, time=2015-12-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2088676, encodeId=d0af20886e68d, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, createdName=839640778, createdTime=Sat Sep 05 12:23:00 CST 2015, time=2015-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1968149, encodeId=171a196814941, content=<a href='/topic/show?id=e9a9e45455' target=_blank style='color:#2F92EE;'>#Finerenone#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7454, encryptionId=e9a9e45455, topicName=Finerenone)], 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authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:14:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57355, encodeId=1a565e355cb, content=漫长的等待,不过也是值得的,, beContent=null, objectType=article, channel=null, level=null, likeNumber=102, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:14:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57356, encodeId=93e45e356c0, content=嗯,不错,, beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:14:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57357, encodeId=629f5e3572c, content=嗯,不错,, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:14:00 CST 2016, time=2016-01-14, status=1, ipAttribution=)]
    2016-01-14 medsic

    漫长的等待,不过也是值得的,

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=2089223, encodeId=25fa208922336, content=<a href='/topic/show?id=e9a9e45455' target=_blank style='color:#2F92EE;'>#Finerenone#</a>对慢性<a href='/topic/show?id=072c5088466' target=_blank style='color:#2F92EE;'>#心力衰竭#</a>和<a href='/topic/show?id=e02e1048003f' target=_blank style='color:#2F92EE;'>#糖尿病性肾病#</a>,又是一代新药, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7454, encryptionId=e9a9e45455, topicName=Finerenone), TopicDto(id=50884, encryptionId=072c5088466, topicName=心力衰竭), TopicDto(id=104800, encryptionId=e02e1048003f, topicName=糖尿病性肾病)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=小小医者, createdTime=Tue Sep 20 04:46:33 CST 2022, time=2022-09-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1915874, 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04:23:00 CST 2015, time=2015-12-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2088676, encodeId=d0af20886e68d, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, createdName=839640778, createdTime=Sat Sep 05 12:23:00 CST 2015, time=2015-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1968149, encodeId=171a196814941, content=<a href='/topic/show?id=e9a9e45455' target=_blank style='color:#2F92EE;'>#Finerenone#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7454, encryptionId=e9a9e45455, topicName=Finerenone)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=afa4194, createdName=cenghis, createdTime=Tue Jun 21 03:23:00 CST 2016, time=2016-06-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1931417, encodeId=b94c193141e3f, content=<a href='/topic/show?id=a3d89601f2' target=_blank style='color:#2F92EE;'>#II期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9601, encryptionId=a3d89601f2, topicName=II期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, createdName=kksonne, createdTime=Tue Dec 01 13:23:00 CST 2015, time=2015-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57354, encodeId=48ec5e3540a, content=漫长的等待,不过也是值得的,, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:14:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57355, encodeId=1a565e355cb, content=漫长的等待,不过也是值得的,, beContent=null, objectType=article, channel=null, level=null, likeNumber=102, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:14:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57356, encodeId=93e45e356c0, content=嗯,不错,, beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:14:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57357, encodeId=629f5e3572c, content=嗯,不错,, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:14:00 CST 2016, time=2016-01-14, status=1, ipAttribution=)]
    2016-01-14 medsic

    漫长的等待,不过也是值得的,

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=2089223, encodeId=25fa208922336, content=<a href='/topic/show?id=e9a9e45455' target=_blank style='color:#2F92EE;'>#Finerenone#</a>对慢性<a href='/topic/show?id=072c5088466' target=_blank style='color:#2F92EE;'>#心力衰竭#</a>和<a href='/topic/show?id=e02e1048003f' target=_blank style='color:#2F92EE;'>#糖尿病性肾病#</a>,又是一代新药, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7454, encryptionId=e9a9e45455, topicName=Finerenone), TopicDto(id=50884, encryptionId=072c5088466, topicName=心力衰竭), TopicDto(id=104800, encryptionId=e02e1048003f, topicName=糖尿病性肾病)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=小小医者, createdTime=Tue Sep 20 04:46:33 CST 2022, time=2022-09-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1915874, 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authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:14:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57355, encodeId=1a565e355cb, content=漫长的等待,不过也是值得的,, beContent=null, objectType=article, channel=null, level=null, likeNumber=102, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:14:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57356, encodeId=93e45e356c0, content=嗯,不错,, beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:14:00 CST 2016, time=2016-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57357, encodeId=629f5e3572c, content=嗯,不错,, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:14:00 CST 2016, time=2016-01-14, status=1, ipAttribution=)]
    2016-01-14 medsic

    嗯,不错,

    0

  10. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=57357, encodeId=629f5e3572c, content=嗯,不错,, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32ba1611217, createdName=medsic, createdTime=Thu Jan 14 13:14:00 CST 2016, time=2016-01-14, status=1, ipAttribution=)]
    2016-01-14 medsic

    嗯,不错,

    0