FibroGen, Inc. Reports Dose-finding Data from Phase 2b Study of FG-4592 for Anemia Correction and Maintenance in Chronic Kidney Disease Patients
Published: Nov 15, 2011
SAN FRANCISCO--(BUSINESS WIRE)--FibroGen, Inc., today announced data from an ongoing phase 2b dose-finding study of FG-4592, an investigational hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (PHI), for anemia correction and hemoglobin (Hb) maintenance in patients with stage 3 or 4 chronic kidney disease (CKD) not on dialysis. The study is designed to evaluate several different starting doses, dose frequencies, and dose adjustment schemes of FG-4592 as well as efficacy and safety of FG-4592 over 16- and 24 week-treatment periods. A total of 96 patients were enrolled in the first four treatment arms (n=24 each). Treatment with FG-4592 was designed to increase Hb by at least 1 g/dL and maintain Hb concentration in the target range of 11-13 g/dL for the first two arms (arms A and B) treated for 16 weeks, and 10.5-12.0 g/dL in the second two arms (arms C and D) treated for 24 weeks.