Soluble Ferric Pyrophosphate: Phase IIb data

A double-blind, placebo-controlled, dose-ranging, North American Phase IIb trial in 131 dialysis patients showed that all 4 doses (5, 10, 12 and 15 µg/dL) SFP missed the co-primary efficacy endpoint of >=1.0 g/dL reduction in hemoglobin from baseline to month 6. The company said the endpoint was missed because of the study design and protocol violations. Specifically, the company said the placebo group received 32% more iron than the SFP group in the 2 months prior to enrollment, 29% of subjects received at least one erythropoiesis stimulating agent (ESA) dose change and 15% received IV iron after the baseline hemoglobin measurement. ...