Table 4 Ferumoxytol for Anemia of CKD Trial endpoint and safety evaluations: the MRI substudy

Primary efficacy endpoint

Absolute change in cardiac T2* from Baseline to each follow-up evaluation

Secondary endpoints

•Proportion of patients who develop cardiac T2* value <20 msec at any time point

•Proportion of patients who develop cardiac T2* value <10 msec at any time point

•Change in liver iron concentration as determined by T2* from Baseline to each follow-up evaluation

•Change in pancreatic T2* from Baseline to each follow-up period

•Change in mean ferritin, transferrin saturation, liver function test, and thyroid function test values from Baseline to each follow-up evaluation

•Change in blood glucose and glycosylated hemoglobin from Baseline to each follow-up evaluation