The difference in phosphorous levels between Zerenex and placebo needs to be statistically significant in order for the study to be deemed positive.
Keryx has already run shorter phase III studies of Zerenex demonstrating lowered serum phosphorous levels so there's little reason to believe the long-term study will produce contradictory results.
Zerenex is an iron-based phosphate binder, which is different from competing drugs. Dialysis causes patients to become anemic, requiring treatment with intravenous (IV) iron and erythropoietin-stimulating agents (ESAs) like Amgen's Epogen. Keryx believes Zerenex can grab a significant share of the phosphate binder market if the drug boosts patient iron stores enough to reduce IV iron and/or ESA use.
Along with measuring serum phosphate, the long-term Zerenex study also assesses changes over time in iron levels (ferritin and TSAT levels) and changes in IV iron and ESA use. These are key secondary endpoints of the study.
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