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- W2038407349 abstract "EVALUATION OF FG-4592, A NOVEL ORAL HYPOXIAINDUCIBLE FACTOR PROLYL HYDROXYLASE INHIBITOR, TO TREAT ANEMIA IN HEMODIALYSIS PATIENTS Robert Provenzano, David Goodkin, Stephen Klaus, Peter Linde, Farhad Kazazi, Tyson Lee, Thomas Neff, 3 Peony Yu St. John Hospital & Medical Center, Detroit, MI, Goodkin Biopharma Consulting LLC, Bellevue, WA, FibroGen, Inc., San Francisco, CA. FG-4592, a novel hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), has been shown to increase Hb with transient modest increases in erythropoietin levels in anemic Stage 3-4 CKD patients. We are now evaluating FG-4592 in an ongoing randomized, open-label, active-controlled phase 2 study of hemodialysis patients. At entry, Hb had been maintained at 10.5-13.0 g/dL with IV epoetin alfa thrice-weekly. Iron repletion was not required at baseline. 48 patients were randomized (12:4; FG-4592:epoetin IV) into 3 dose cohorts after stopping epoetin for at least 5 days: 36 to FG-4592 (1.0, 1.5, or 2.0 mg/kg) and 12 to epoetin (at pre-randomization dose) thrice-weekly for 6 weeks. IV iron supplementation, RBC transfusion, and use of erythropoiesis-stimulating agents (unless randomized to epoetin) are not allowed. At abstract submission, 25 protocol-adherent patients treated with 1.0 or 1.5 mg/kg FG-4592 or epoetin have completed ≥4 weeks of treatment with Hb monitoring. The safety and capacity for FG-4592 to maintain corrected Hb in hemodialysis pts will be assessed. Effects of FG-4592 on plasma levels of endogenous EPO, hepcidin, and reticulocyte Hb content will also be assessed. Results of all cohorts will be presented at the scientific congress." @default.
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- W2038407349 date "2011-04-01" @default.
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- W2038407349 title "253 Evaluation of FG-4592, a Novel Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor, to Treat Anemia in Hemodialysis Patients" @default.
- W2038407349 doi "https://doi.org/10.1053/j.ajkd.2011.02.256" @default.
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