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roxadustat治疗合并贫血症的慢性肾病患者达到主要研究终点

2018-09-21 MedSci MedSci原创

安斯泰来制药近日宣布,一项针对慢性肾脏病(CKD)患者的III期临床研究(ALPS试验)表明,roxadustat治疗合并有贫血的慢性肾病患者达到主要终点。在ALPS试验中,相比于安慰剂,HIF-PH抑制剂roxadustat表现出显著的前24周血红蛋白(Hb)反应率和第28周至第52周Hb从基线变化的优势。

安斯泰来制药近日宣布,一项针对慢性肾脏病(CKD)患者的III临床研究(ALPS试验)表明,roxadustat治疗合并有贫血的慢性肾病患者达到主要终点。在ALPS试验中,相比于安慰剂,HIF-PH抑制剂roxadustat表现出显著的前24周血红蛋白(Hb)反应率和第28周至第52Hb从基线变化的优势。

慢性肾脏病是指肾功能在几个月或若干年期间逐渐而难以逆转的衰退。据估计,慢性肾病患者占美国成年人口的13%,而大多数患者对自身病情往往并不自知。该研究将合并贫血的CKD且未接受透析的患者随机分组接受roxadustat或安慰剂治疗52104周。安斯泰来指出,第一个主要终点是在前24周内获得Hb反应的患者比例,这是在美国寻求批准所需的,而第二个主要终点是Hb在第28周至第52周从基线的变化,这是在欧洲寻求批准所需的。据该公司称,初步安全性分析显示整体不良反应事件概况与先前研究一致,安斯泰来补充说,该试验的进一步结果预计将在未来报道。


原始出处:

http://www.firstwordpharma.com/node/1592245#axzz5RicJI7Is

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    2018-09-24 一个字-牛

    学习了谢谢分享

    0

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  6. [GetPortalCommentsPageByObjectIdResponse(id=2055958, encodeId=ee032055958be, content=<a href='/topic/show?id=d088536467a' target=_blank style='color:#2F92EE;'>#慢性肾病患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53646, encryptionId=d088536467a, topicName=慢性肾病患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=568152, createdName=snowpeakxu, createdTime=Thu Aug 15 23:40:00 CST 2019, time=2019-08-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1776810, encodeId=c9f71e768106f, content=<a href='/topic/show?id=5b989244667' target=_blank style='color:#2F92EE;'>#贫血症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92446, encryptionId=5b989244667, topicName=贫血症)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=81a339030187, createdName=medscijoin, createdTime=Fri Oct 05 03:40:00 CST 2018, time=2018-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2025844, encodeId=03d32025844f9, content=<a href='/topic/show?id=a91d82583bf' target=_blank style='color:#2F92EE;'>#肾病患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82583, encryptionId=a91d82583bf, topicName=肾病患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=db5b227, createdName=gostraight, createdTime=Sat Sep 07 00:40:00 CST 2019, time=2019-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=346428, encodeId=d5ee34642863, content=学习了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=102, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160304/IMG56D94856B1B5D6405.jpg, createdBy=27931687771, createdName=一个字-牛, createdTime=Mon Sep 24 11:36:30 CST 2018, time=2018-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548116, encodeId=21cb1548116f8, content=<a href='/topic/show?id=f9d315653b0' target=_blank style='color:#2F92EE;'>#roxadustat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15653, encryptionId=f9d315653b0, topicName=roxadustat)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=94de13994922, createdName=小小小向日葵, createdTime=Sun Sep 23 06:40:00 CST 2018, time=2018-09-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=346051, encodeId=e70334605101, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=132, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Fri Sep 21 22:00:04 CST 2018, time=2018-09-21, status=1, ipAttribution=)]
    2018-09-21 医者仁心5538

    学习了

    0

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