Table 3 Ferumoxytol for Anemia of CKD Trial endpoints and safety evaluations: main study and oxidative stress substudy

Primary efficacy endpoint

•Mean change in hemoglobin from Baseline to Week 5 for each treatment period

Secondary efficacy endpoints

•Mean change in transferrin saturation from Baseline to Week 5 for each treatment period

•Proportion of patients with an increase in hemoglobin of ≥1.0 g/dL at any time from Baseline to Week 5 for each treatment period

Safety evaluations

•An evaluation of the AE profile over the course of the study and following each course of ferumoxytol or iron sucrose, including serious AEs, AEs leading to study drug discontinuation, all AEs, vital signs (blood pressure, heart rate, respiration rate, and body temperature); physical examination findings; and routine laboratory parameters (hematology, chemistry, and iron panel)

Exploratory endpoints

•Time to subsequent treatment courses of ferumoxytol or iron sucrose

•Cumulative intravenous iron exposure per patient over the course of the study

•Proportion of patients requiring blood transfusion

•Proportion of patients who had a change in ESA dose (≥20% increase or decrease or initiation/cessation of ESA therapy) over the course of the study

Exploratory endpoints

Mean change in the following blood biomarkers from Baseline to Week 5 of the initial treatment period in the main study:

•Protein carbonyl content

•13-hydroxyoctadecadienoic acid

•4-hydroxynonenal

•Monocyte chemoattractant protein-1

•Neutrophil gelatinase-associated lipocalin

•High-sensitivity interleukin-6