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      Roxadustat (FG-4592): Correction of Anemia in Incident Dialysis Patients

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          Abstract

          Safety concerns with erythropoietin analogues and intravenous (IV) iron for treatment of anemia in CKD necessitate development of safer therapies. Roxadustat (FG-4592) is an orally bioavailable hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor that promotes coordinated erythropoiesis through HIF-mediated transcription. We performed an open-label, randomized hemoglobin (Hb) correction study in anemic (Hb≤10.0 g/dl) patients incident to hemodialysis (HD) or peritoneal dialysis (PD). Sixty patients received no iron, oral iron, or IV iron while treated with roxadustat for 12 weeks. Mean±SD baseline Hb was 8.3±1.0 g/dl in enrolled patients. Roxadustat at titrated doses increased mean Hb by ≥2.0 g/dl within 7 weeks regardless of baseline iron repletion status, C-reactive protein level, iron regimen, or dialysis modality. Mean±SEM maximal change in Hb from baseline ( ΔHb max), the primary endpoint, was 3.1±0.2 g/dl over 12 weeks in efficacy-evaluable patients ( n=55). In groups receiving oral or IV iron, ΔHb max was similar and larger than in the no-iron group. Hb response (increase in Hb of ≥1.0 g/dl from baseline) was achieved in 96% of efficacy-evaluable patients. Mean serum hepcidin decreased significantly 4 weeks into study: by 80% in HD patients receiving no iron ( n=22), 52% in HD and PD patients receiving oral iron ( n=21), and 41% in HD patients receiving IV iron ( n=9). In summary, roxadustat was well tolerated and corrected anemia in incident HD and PD patients, regardless of baseline iron repletion status or C-reactive protein level and with oral or IV iron supplementation; it also reduced serum hepcidin levels.

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          Author and article information

          Journal
          J Am Soc Nephrol
          J. Am. Soc. Nephrol
          jnephrol
          jnephrol
          ASN
          Journal of the American Society of Nephrology : JASN
          American Society of Nephrology
          1046-6673
          1533-3450
          April 2016
          22 October 2015
          : 27
          : 4
          : 1225-1233
          Affiliations
          [* ]FibroGen, Inc., San Francisco, California;
          []Budgetary Healthcare Institution of Omsk Region, City Clinical Hospital #1, Omsk, Russia;
          []City Hospital #33, Nizhny Novgorod, Russia;
          [§ ]State Budgetary Healthcare Institution of Moscow, City Clinical Hospital, Moscow, Russia;
          []Division of Nephrology and Hypertension, Henry Ford Hospital, Detroit, Michigan;
          []Fresenius Medical Care, St. Petersburg, Russia; and
          [** ]Division of Nephrology, Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong
          Author notes
          Correspondence: Dr. Anatole Besarab, FibroGen, Inc., 409 Illinois Street, San Francisco, CA. abesarab@ 123456fibrogen.com
          Article
          PMC4814189 PMC4814189 4814189 2015030241
          10.1681/ASN.2015030241
          4814189
          26494833
          Copyright © 2016 by the American Society of Nephrology
          Page count
          Pages: 9
          Categories
          Clinical Research
          Custom metadata
          April 2016

          erythropoietin, chronic kidney disease, dialysis, anemia

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