U.S. Renal Care Enrolled First Patients in the VOICE Collaborative Clinical Trial of Vafseo® (vadadustat) for CKD Patients on Dialysis

PR Newswire2024-12-03

Outcomes study will assess mortality and hospitalization in patients treated with Vafseo compared to current standard of care CAMBRIDGE, Mass., Dec. 3, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. ...

Source Link

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2488193689?lang=en_US&edition=fundamental","thumbnail":"https://s.yimg.com/uu/api/res/1.2/TC3ZCpWljA1qxdUAc3L0mw--~B/aD0xNjM7dz00MDA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/prnewswire.com/0ab1720f444c3184a18a33bd946181b8","is_english":true,"pubTime":"2024-12-03 20:00","share_image_url":"https://static.laohu8.com/5f26f4a48f9cb3e29be4d71d3ba8c038","id":"2488193689","market":"us","top_or_hot":-1,"title":"U.S. Renal Care Enrolled First Patients in the VOICE Collaborative Clinical Trial of Vafseo® (vadadustat) for CKD Patients on Dialysis","media":"PR Newswire","content":"<div>\n<p>Outcomes study will assess mortality and hospitalization in patients treated with Vafseo compared to current standard of care\nCAMBRIDGE, Mass., Dec. 3, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. ...</p>\n\n<a href=\"https://finance.yahoo.com/news/u-renal-care-enrolled-first-120000445.html\">Source Link</a>\n\n</div>\n","source":"yahoofinance","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>U.S. Renal Care Enrolled First Patients in the VOICE Collaborative Clinical Trial of Vafseo® (vadadustat) for CKD Patients on Dialysis</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nU.S. Renal Care Enrolled First Patients in the VOICE Collaborative Clinical Trial of Vafseo® (vadadustat) for CKD Patients on Dialysis\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-12-03 20:00 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/u-renal-care-enrolled-first-120000445.html><strong>PR Newswire</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Outcomes study will assess mortality and hospitalization in patients treated with Vafseo compared to current standard of care\nCAMBRIDGE, Mass., Dec. 3, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. ...</p>\n\n<a href=\"https://finance.yahoo.com/news/u-renal-care-enrolled-first-120000445.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4157","symbol_name":"电子设备和仪器","start_time":0,"source_url":"https://finance.yahoo.com/news/u-renal-care-enrolled-first-120000445.html","article_id":"2488193689","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/TC3ZCpWljA1qxdUAc3L0mw--~B/aD0xNjM7dz00MDA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/prnewswire.com/0ab1720f444c3184a18a33bd946181b8"],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/u-renal-care-enrolled-first-120000445.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2488193689","pubTimestamp":1733227200,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Outcomes study will assess mortality and hospitalization in patients treated with Vafseo compared to current standard of care. CAMBRIDGE, Mass., Dec. 3, 2024 /PRNewswire/ -- Akebia Therapeutics, Inc. , a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, announced that in late November U.S. Renal Care  enrolled the first patient in its Vafseo Outcomes In-Center Experience  collaborative trial. Akebia announced the collaborative trial initiationin September 2024.\"We look forward to begin treating CKD anemia patients on dialysis with Vafseo ahead of its anticipated market launch in January 2025,\" said Steven K. Burke, M.D., Chief Medical Officer of Akebia. \"The study has been designed to evaluate Vafseo safety and efficacy when dosed three times a week to align with patients' current dialysis schedule as well as to explore additional potential patient benefits. We congratulate Dr. Geoff Block and his team at USRC on quickly consenting pat","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4157":"电子设备和仪器","BK4077":"互动媒体与服务","MACE":"Mace Security International, Inc.","USRC":"Unisource Corp.","MI":"NFT Limited","BK4139":"生物科技","LU2065731478.USD":"ALLSPRING (LUX) WORLDWIDE FUND - SMALL CAP INNOVA \"I\" (USD) ACC","IE00B64QTZ34.USD":"NEUBERGER BERMAN US SMALL CAP \"A\" (USD) ACC","IE00BLDYK493.USD":"NEUBERGER BERMAN US SMALL CAP \"A\" (USD) INC","BK4183":"个人用品","BK4161":"工业机械","AKBA":"Akebia Therapeutics, Inc.","RBC":"RBC轴承"},"translate_title":"U.S.Renal Care在Vafseo®（vadadustat）针对CKD透析患者的VOICE协作临床试验中招募了第一批患者","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"MACE":1,"MI":1,"RBC":1,"USRC":1,"AKBA":0.9},"content_text":"Outcomes study will assess mortality and hospitalization in patients treated with Vafseo compared to current standard of care\nCAMBRIDGE, Mass., Dec. 3, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, announced that in late November U.S. Renal Care (USRC) enrolled the first patient in its Vafseo® (vadadustat) Outcomes In-Center Experience (VOICE) collaborative trial. Akebia announced the collaborative trial initiation in September 2024.\n\n  \n\n\"We look forward to begin treating CKD anemia patients on dialysis with Vafseo ahead of its anticipated market launch in January 2025,\" said Steven K. Burke, M.D., Chief Medical Officer of Akebia. \"The study has been designed to evaluate Vafseo safety and efficacy when dosed three times a week to align with patients' current dialysis schedule as well as to explore additional potential patient benefits. We congratulate Dr. Geoff Block and his team at USRC on quickly consenting patients for the study and thank him for his commitment to patients impacted by kidney disease.\"\nVafseo was approved by the U.S. Food and Drug Administration in March 2024 for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo is approved for once-daily oral administration and is expected to be available in the U.S. in January 2025.\nThe VOICE trial intends to enroll approximately 2,200 patients who will be randomized to oral Vafseo 300 mg tablets administered three times per week or standard-of-care erythropoiesis-stimulating agents. The trial will end approximately 18 months after the last patient is randomized. The primary endpoint is non-inferiority for all-cause mortality and the secondary endpoint will test superiority of Vafseo to reduce all-cause hospitalization. More information about the VOICE trial can be found here.\nAbout U.S. Renal Care\nU.S. Renal Care partners with nephrologists across 32 states in the U.S. to care for more than 36,000 people living with kidney disease. Since 2000, U.S. Renal Care has been a leader in clinical quality, innovation, and operational excellence – delivering the best experience and outcomes for our patients. For more information, visit USRenalCare.com.\nAbout Akebia Therapeutics\nAkebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.\nAbout Vafseo® (vadadustat) tablets \nVafseo® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries.\nINDICATION\nVAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.\nLimitations of Use\n\nVAFSEO has not been shown to improve quality of life, fatigue, or patient well-being.\nVAFSEO is not indicated for use:\n   \nAs a substitute for red blood cell transfusions in patients who require immediate correction of anemia.\nIn patients with anemia due to CKD not on dialysis.\n\n\nIMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets\nWARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS.\nVAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). \nTargeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels. \nNo trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks. \nUse the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions.\nCONTRAINDICATIONS \n\nKnown hypersensitivity to VAFSEO or any of its components\nUncontrolled hypertension\n\nWARNINGS AND PRECAUTIONS \n\nIncreased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access\n\nA rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis.\n\nHepatotoxicity\n\nHepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease.\n\nHypertension\n\nWorsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed.\n\nSeizures \n\nSeizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency.\n\nGastrointestinal (GI) Erosion \n\nGastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present.\n\nSerious Adverse Reactions in Patients with Anemia Due to CKD and Not on Dialysis \n\nThe safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa.\n\nMalignancy\n\nVAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies.\nADVERSE REACTIONS \n\nThe most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea.\n\nDRUG INTERACTIONS\n\nIron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron.\nNon-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders.\nBCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction.\nStatins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg.\n\nUSE IN SPECIFIC POPULATIONS\n\nPregnancy: May cause fetal harm.\nLactation: Breastfeeding not recommended until two days after the final dose.\nHepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease.\n\nPlease note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide. \nForward-Looking Statements\nStatements in this press release regarding Akebia Therapeutics, Inc.'s (\"Akebia's\") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding:  Akebia's expectations regarding the VOICE trial, including expectations as to the potential benefits and risks of Vafseo when dosed three times a week in dialysis patients, and Akebia's expectations as to the timing of the market availability of Vafseo in the U.S. The terms \"intend,\" \"believe,\" \"plan,\" \"goal,\" \"potential,\" \"anticipate, \"estimate,\" \"expect,\" \"future,\" \"will,\" \"continue,\" derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: whether Vafseo will be commercially available when expected; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; the results of preclinical and clinical research; the potential therapeutic benefits, safety profile, and effectiveness of Vafseo; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to Vafseo; the competitive landscape for Vafseo; the ability of Akebia to attract and retain qualified personnel; decisions made by health authorities, such as the FDA, with respect to regulatory filings; the direct or indirect impact of the COVID-19 pandemic on the markets and communities in which Akebia and its partners, collaborators, vendors and customers operate; and early termination of any of Akebia's collaborations. Other risks and uncertainties include those identified under the heading \"Risk Factors\" in Akebia's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.\nAkebia Therapeutics® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc.\nAkebia Therapeutics ContactMercedes Carrascomcarrasco@akebia.com\n View original content to download multimedia:https://www.prnewswire.com/news-releases/us-renal-care-enrolled-first-patients-in-the-voice-collaborative-clinical-trial-of-vafseo-vadadustat-for-ckd-patients-on-dialysis-302320302.html\nSOURCE Akebia Therapeutics, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.30.0","shortVersion":"4.30.0","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2488193689"}