Biotech Values

[ghmm]

FGEN:

Randomized placebo-controlled dose-ranging and pharmacodynamics study of roxadustat (FG-4592) to treat anemia in nondialysis-dependent chronic kidney disease (NDD-CKD) patients

PR: http://finance.yahoo.com/news/nephrology-dialysis-transplantation-reports-phase-221819000.html

http://www.ncbi.nlm.nih.gov/m/pubmed/26238121/#fft
H/t Jason @JasonHolman5


Besarab A, et al. Nephrol Dial Transplant. 2015.
Authors
Besarab A1, Provenzano R2, Hertel J3, Zabaneh R4, Klaus SJ1, Lee T1, Leong R1, Hemmerich S1, Yu KP1, Neff TB1.
Author information
1FibroGen, Inc., San Francisco, CA, USA.
2St Clair Specialty Physicians, Detroit, MI, USA.
3Kidney Care Associates, LLC, Augusta, GA, USA.
4Northwest Louisiana Nephrology, Shreveport, LA, USA.
Citation
Nephrol Dial Transplant. 2015 Aug 3. pii: gfv302. [Epub ahead of print]
Abstract
BACKGROUND: Roxadustat (FG-4592) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis. This Phase 2a study tested efficacy (Hb response) and safety of roxadustat in anemic nondialysis-dependent chronic kidney disease (NDD-CKD) subjects.

METHODS: NDD-CKD subjects with hemoglobin (Hb) =11.0 g/dL were sequentially enrolled into four dose cohorts and randomized to roxadustat or placebo two times weekly (BIW) or three times weekly (TIW) for 4 weeks, in an approximate roxadustat:placebo ratio of 3:1. Efficacy was assessed by (i) mean Hb change (?Hb) from baseline (BL) and (ii) proportion of Hb responders (?Hb = 1.0 g/dL). Pharmacodynamic evaluation was performed in a subset of subjects. Safety was evaluated by adverse event frequency/severity.

RESULTS: Of 116 subjects receiving treatment, 104 completed 4 weeks of dosing and 96 were evaluable for efficacy. BL characteristics for roxadustat and placebo groups were comparable. In roxadustat-treated subjects, Hb levels increased from BL in a dose-related manner in the 0.7, 1.0, 1.5 and 2.0 mg/kg groups. Maximum ?Hb within the first 6 weeks was significantly higher in the 1.5 and 2.0 mg/kg groups than in the placebo subjects. Hb responder rates were dose dependent and ranged from 30% in the 0.7 mg/kg BIW group to 100% in the 2.0 mg/kg BIW and TIW groups versus 13% in placebo.

CONCLUSIONS: Roxadustat transiently and moderately increased endogenous erythropoietin and reduced hepcidin. Adverse events were similar in the roxadustat and placebo groups. Roxadustat produced dose-dependent increases in blood Hb among anemic NDD-CKD patients in a placebo-controlled trial.

CLINICAL TRIALS REGISTRATION: Clintrials.gov #NCT00761657.

© The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.
PMID 26238121 [PubMed - as supplied by publisher]