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Phase 2 studies of oral hypoxia-inducible factor prolyl hydroxylase inhibitor FG-4592 for treatment of anemia in China.
- Source :
- Nephrology Dialysis Transplantation; Aug2017, Vol. 32 Issue 8, p1373-1386, 14p, 1 Diagram, 3 Charts, 2 Graphs
- Publication Year :
- 2017
-
Abstract
- Background. 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). Methods. 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. Results. 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 < 0.0001, both). In the DD study, 59.1%, 88.9% (P = 0.008) and 100% (P = 0.0003) of the low-, medium- and high-dose subjects maintained their Hb levels after 5- and 6-weeks versus 50% of the epoetin alfa-treated subjects. Conclusions. FG-4592 may prove an effective alternative for managing anemia of CKD. It is currently being investigated in a pivotal global Phase 3 program. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 09310509
- Volume :
- 32
- Issue :
- 8
- Database :
- Complementary Index
- Journal :
- Nephrology Dialysis Transplantation
- Publication Type :
- Academic Journal
- Accession number :
- 124464080
- Full Text :
- https://doi.org/10.1093/ndt/gfx011