{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T22:16:26Z","timestamp":1783116986826,"version":"3.54.6"},"reference-count":33,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2020,6,30]],"date-time":"2020-06-30T00:00:00Z","timestamp":1593475200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/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":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Roxadustat (FG\u20104592), an oral hypoxia\u2010inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis, was evaluated in a phase 1b study in patients with end\u2010stage renal disease with anemia on hemodialysis. Seventeen patients, on epoetin\u2010alfa maintenance therapy with stable hemoglobin levels \u226510\u00a0g\/dL, had epoetin\u2010alfa discontinued on day 3 and were enrolled in this double\u2010blind placebo\u2010controlled study. Two cohorts were randomized 3:1 (roxadustat: placebo). Patients received single doses of roxadustat (1 or 2\u00a0mg\/kg) or placebo 1 hour after hemodialysis on day 1 and 2 hours before dialysis on day 8. Maximum plasma concentration and area under the plasma concentration\u2013time curve for patients receiving roxadustat were slightly more than dose proportional and elimination half\u2010life ranged from 14.7 to 19.4\u00a0hours. Roxadustat was highly protein bound (99%) in plasma, and dialysis contributed a small fraction of the total clearance: only 4.56% and 3.04% of roxadustat recovered from the 1 and 2\u00a0mg\/kg dose groups, respectively. Roxadustat induced transient elevations of endogenous erythropoietin that peaked between 7 and 14 hours after dosing and returned to baseline by 48 hours after dosing. Peak median endogenous erythropoietin levels were 96\u00a0mIU\/mL and 268\u00a0mIU\/mL for the 1\u2010 and 2\u2010mg\/kg doses, respectively, within physiologic range of endogenous erythropoietin responses to hypoxia at high altitude or after blood loss. No serious adverse events were reported, and there were no treatment\u2010 or dose\u2010related trends in adverse event incidence.<\/jats:p>","DOI":"10.1002\/jcph.1648","type":"journal-article","created":{"date-parts":[[2020,6,30]],"date-time":"2020-06-30T18:18:54Z","timestamp":1593541134000},"page":"1432-1440","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Oral Hypoxia\u2010Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat (FG\u20104592) for Treatment of Anemia in Chronic Kidney Disease: A Placebo\u2010Controlled Study of Pharmacokinetic and Pharmacodynamic Profiles in Hemodialysis Patients"],"prefix":"10.1002","volume":"60","author":[{"given":"Robert","family":"Provenzano","sequence":"first","affiliation":[{"name":"Department of Medicine Wayne State University  Detroit Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Tumlin","sequence":"additional","affiliation":[{"name":"Southeast Renal Research Institute  Chattanooga Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raja","family":"Zabaneh","sequence":"additional","affiliation":[{"name":"Northwest Louisiana Nephrology Research  Shreveport Louisiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Chou","sequence":"additional","affiliation":[{"name":"FibroGen, Inc.  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Hemmerich","sequence":"additional","affiliation":[{"name":"FibroGen, Inc.  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas B.","family":"Neff","sequence":"additional","affiliation":[{"name":"FibroGen, Inc.  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.\u2010H. Peony","family":"Yu","sequence":"additional","affiliation":[{"name":"FibroGen, Inc.  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,6,30]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"US Center of Disease Control.National Chronic Kidney Disease Fact Sheet. Center for Disease Control and Prevention Website.https:\/\/www.cdc.gov\/diabetes\/pubs\/pdf\/kidney_factsheet.pdf. Published 2017. 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