Table 2.

United States epoetin hospira human studies

Study NumberDescriptionNPredefined End PointsResultsAdverse Events
EPOE-12–02Single-center, open-label, randomized PK/PD study of epoetin hospira versus Epogen/Procrit after single 100 U/kg SC dose in healthy subjects81Epoetin AUC and Cmax; reticulocyte AUEC and EmaxPK and PD similarity with 90% CI for ratios of geographic means within 80%–125% as prespecified by FDA
EPOE-14–01Single-center, open-label, parallel group PK/PD study of epoetin hospira versus Epogen/Procrit after 100 U/kg SC tiw for 4 wk in healthy subjects129Hb AUC at 28 d; epoetin AUC and Cmax after final dosePK and PD similarity with 90% CI for ratios of geographic means within 80%–125% as prespecified by FDA
EPOE-10–13Randomized, double-blind, parallel group study of SC epoetin hospira versus Epogen/Procrit in patients receiving HD previously receiving iv Epogen/Procrit246Mean weekly epoetin dose and mean weekly Hb during last 4 wk of treatmentNo clinically meaningful differencesNo significant differences
EPOE-10–01Randomized, double-blind, parallel group study of iv epoetin hospira versus Epogen/Procrit in patients receiving HD previously receiving iv Epogen/Procrit612Mean weekly epoetin dose and mean weekly Hb during last 4 wk of treatmentNo clinically meaningful differencesNo significant differences
  • PK, pharmacokinetic; PD, pharmacodynamic; SC, subcutaneous; AUC, area under curve; Cmax, maximum concentration; AUEC, area under effect curve; Emax, maximum effect; 90% CI, 90% confidence interval; FDA, Food and Drug Administration; tiw, three times weekly; Hb, hemoglobin level; HD, hemodialysis; iv, intravenous.