{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T04:20:14Z","timestamp":1784262014282,"version":"3.55.0"},"reference-count":20,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2023,6,28]],"date-time":"2023-06-28T00:00:00Z","timestamp":1687910400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006591","name":"FibroGen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006591","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hemodialysis International"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Roxadustat is an oral hypoxia\u2010inducible factor prolyl hydroxylase inhibitor approved in several regions for the treatment of anemia of chronic kidney disease (CKD). ASPEN evaluated the efficacy, safety, and feasibility of roxadustat in patients with anemia of CKD in US dialysis organizations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This open\u2010label, single\u2010arm study (NCT04484857) comprised a 6\u2010week screening period, followed by 24\u2009weeks of treatment (with optional extension \u22641\u2009year) and a 4\u2010week follow\u2010up. Patients aged \u226518\u2009years, receiving chronic dialysis, with hemoglobin (Hb) 9.0\u201312.0\u2009g\/dL if converting from erythropoiesis\u2010stimulating agents (ESAs), or &lt;10.0\u2009g\/dL if receiving ESAs for &lt;6\u2009weeks, received oral roxadustat three times weekly in\u2010center. Primary efficacy endpoints included proportion of patients with mean Hb \u226510\u2009g\/dL, averaged over weeks 16\u201324, and mean Hb change from baseline to the average over weeks 16\u201324. Safety was also assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Findings<\/jats:title><jats:p>Overall, 283 patients were enrolled and treated, 282 (99.6%) were included in the full analysis set, and 216 (76.3%) continued into the extension period. Most patients enrolled were from DaVita sites (71%), with the rest from US Renal Care sites (29%). Mean (standard deviation [<jats:italic>SD<\/jats:italic>]) baseline Hb was 10.6 (0.7)\u2009g\/dL. Nearly all patients were prior ESA users (<jats:italic>n<\/jats:italic>\u2009=\u2009274; 97.2%). The proportion of patients with mean Hb \u226510\u2009g\/dL during weeks 16\u201324 was 83.7% (95% confidence interval 78.9\u201388.6). Mean (<jats:italic>SD<\/jats:italic>) Hb increase from baseline to the average over weeks 16\u201324 was 0.2 (1.0)\u2009g\/dL. During the treatment period, 82 (29.0%) patients reported treatment\u2010emergent serious adverse events (TESAEs). The most common TESAEs were COVID\u201019 pneumonia (<jats:italic>n<\/jats:italic>\u2009=\u200910; 3.5%), acute respiratory failure (<jats:italic>n<\/jats:italic>\u2009=\u20099; 3.2%), COVID\u201019 (<jats:italic>n<\/jats:italic>\u2009=\u20097; 2.5%), acute myocardial infarction (<jats:italic>n<\/jats:italic>\u2009=\u20097; 2.5%), and fluid overload (<jats:italic>n<\/jats:italic>\u2009=\u20096, 2.1%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>Roxadustat was effective in maintaining Hb in patients with anemia of CKD on dialysis in large, community\u2010based dialysis organizations.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hdi.13100","type":"journal-article","created":{"date-parts":[[2023,6,29]],"date-time":"2023-06-29T01:14:32Z","timestamp":1688001272000},"page":"400-410","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A phase 3b, multicenter, open\u2010label, single\u2010arm study of roxadustat (<scp>ASPEN<\/scp>): Operational learnings within United States dialysis organizations"],"prefix":"10.1111","volume":"27","author":[{"given":"Steven","family":"Fishbane","sequence":"first","affiliation":[{"name":"Department of Medicine Donald and Barbara Zucker School of Medicine at Hofstra\/Northwell  Great Neck New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Vishnepolsky","sequence":"additional","affiliation":[{"name":"Kidney Specialists of Southern Nevada Las Vegas  Las Vegas Nevada USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yemmie","family":"Oluwatosin","sequence":"additional","affiliation":[{"name":"Medical Affairs, AstraZeneca  Wilmington Delaware USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline","family":"Nolen","sequence":"additional","affiliation":[{"name":"FibroGen Inc.  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lixia","family":"Zhu","sequence":"additional","affiliation":[{"name":"FibroGen Inc.  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kerry","family":"Cooper","sequence":"additional","affiliation":[{"name":"Medical Affairs, AstraZeneca  Wilmington Delaware USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Young","sequence":"additional","affiliation":[{"name":"DaVita Clinical Research  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,6,28]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1155\/2020\/7692376"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2012080855"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-017-0566-z"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.3949\/ccjm.83a.15065"},{"key":"e_1_2_9_6_1","first-page":"335","article-title":"KDIGO clinical practice guideline for anemia in chronic kidney disease","volume":"2","author":"Kidney Disease Improving Global Outcomes","year":"2012","journal-title":"Kidney Int Suppl"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2008.295"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.02380607"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp0912328"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2020081150"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2020111638"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ekir.2021.04.007"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfab051"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfab057"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ekir.2020.11.034"},{"key":"e_1_2_9_16_1","unstructured":"The DOPPS Practice Monitor.DOPPS practice monitor \u2010 hemodialysis. 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