The open-label, multi-center, randomized study in chronic kidney disease (CKD) patients on hemodialysis demonstrated a statistically significant achievement of all the primary and secondary endpoints, the company said.
The study enrolled 230 hemodialysis dependent CKD patients who were receiving stable doses of erythropoietin therapy. Patients were randomized 1:1 to receive either two 510mg doses of IV ferumoxytol within one week or 200mg of oral iron daily for three weeks.
The primary endpoint was the mean change in hemoglobin from baseline at day 35 after the first dose. The secondary endpoints included the proportion of patients with at least a 1.0 g/dL rise in hemoglobin at day 35, and the mean change in serum ferritin from baseline to day 21.
Adverse events occurred in 49.1% of patients after ferumoxytol administration and in 56.6% of patients after oral iron administration.
“Now that the execution phase of our pivotal program in CKD patients is complete, we are focused on the preparation of the ferumoxytol new drug application filing, which is on track for the fourth calendar quarter of 2007,” said Brian Pereira, president and CEO of Advanced Magnetics.