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Phase 2 studies of oral hypoxia-inducible factor prolyl hydroxylase inhibitor FG-4592 for treatment of anemia in China.


ABSTRACT: FG-4592 (roxadustat) is an oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (HIF-PHI) promoting coordinated erythropoiesis through the transcription factor HIF. Two Phase 2 studies were conducted in China to explore the safety and efficacy of FG-4592 (USAN name: roxadustat, CDAN name: ), a HIF-PHI, in patients with anemia of chronic kidney disease (CKD), both patients who were dialysis-dependent (DD) and patients who were not dialysis-dependent (NDD).In the NDD study, 91 participants were randomized to low (1.1-1.75?mg/kg) or high (1.50-2.25?mg/kg) FG-4592 starting doses or to placebo. In the DD study, 87 were enrolled to low (1.1-1.8?mg/kg), medium (1.5-2.3?mg/kg) and high (1.7-2.3?mg/kg) starting FG-4592 doses or to continuation of epoetin alfa. In both studies, only oral iron supplementation was allowed.In the NDD study, hemoglobin (Hb) increase??1?g/dL from baseline was achieved in 80.0% of subjects in the low-dose cohort and 87.1% in the high-dose cohort, versus 23.3% in the placebo arm (P?

SUBMITTER: Chen N 

PROVIDER: S-EPMC5837707 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Phase 2 studies of oral hypoxia-inducible factor prolyl hydroxylase inhibitor FG-4592 for treatment of anemia in China.

Chen Nan N   Qian Jiaqi J   Chen Jianghua J   Yu Xueqing X   Mei Changlin C   Hao Chuanming C   Jiang Gengru G   Lin Hongli H   Zhang Xinzhou X   Zuo Li L   He Qiang Q   Fu Ping P   Li Xuemei X   Ni Dalvin D   Hemmerich Stefan S   Liu Cameron C   Szczech Lynda L   Besarab Anatole A   Neff Thomas B TB   Peony Yu Kin-Hung KH   Valone Frank H FH  

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association 20170801 8


<h4>Background</h4>FG-4592 (roxadustat) is an oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (HIF-PHI) promoting coordinated erythropoiesis through the transcription factor HIF. Two Phase 2 studies were conducted in China to explore the safety and efficacy of FG-4592 (USAN name: roxadustat, CDAN name: ), a HIF-PHI, in patients with anemia of chronic kidney disease (CKD), both patients who were dialysis-dependent (DD) and patients who were not dialysis-dependent (NDD).<h4>Method  ...[more]

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