Phase III trial data for Auryxia in iron deficiency anemia published in American Journal of Hematology.- Keryx Biopharmaceuticals.

Keryx Biopharmaceuticals announced the publication of a post-hoc analysis of Auryxia (ferric citrate) phase III trial data for iron deficiency anemia in adult patients with chronic kidney disease (CKD), not on dialysis, in the online issue of the American Journal of Hematology. The article describes associations of baseline demographic, clinical and laboratory variables with change in hemoglobin in ferric citrate-treated patients. In the phase III study, 234 patients were randomized to receive ferric citrate (n=117) or placebo (n=117).

The full results of the study were published in January 2017 in the Journal of the American Society of Nephrology. This post-hoc analysis assessed the intent-to-treat population (ferric citrate, n=117; placebo, n=115). Baseline characteristics were similar across treatment groups. Results of this multivariable regression analysis show the following variables were associated with greater hemoglobin increases from baseline at 16 weeks: ferric citrate treatment, lower baseline hemoglobin (p=.0160), higher serum albumin (p=.0007), lower intact fibroblast growth factor 23 (FGF23) (p=.0024), and lower transferrin saturation (TSAT) (p=.0189). Treatment interactions were observed for TSAT and ferritin only.

See: "Hemoglobin Response to Ferric Citrate in Patients with Non-dialysis-dependent Chronic Kidney Disease and Iron Deficiency Anemia,� Pablo E. Pergola et al. American Journal of Hematology 30 March 2018 https://doi.org/10.1002/ajh.25088