The trial is the fourth and final planned multi-center study in the company’s phase III development program for ferumoxytol, an intravenous iron replacement therapeutic for the treatment of anemia in chronic kidney disease patients.
Patients were randomized to receive either two 510 mg doses of ferumoxytol within one week or 200 mg of oral iron daily for three weeks. The primary endpoint is the mean change in hemoglobin from baseline in the ferumoxytol group compared to that in the oral iron treatment group.
The company plans to file a New Drug Application (NDA) with the FDA for the marketing approval of ferumoxytol in the fourth calendar quarter of 2007.
“Having achieved the important milestone of completing patient enrollment in our phase III development program, we now look forward to presenting results from multiple trials in the weeks and months ahead, and remain focused on the day that ferumoxytol might become available to all chronic kidney disease patients and physicians,” said Brian Pereira, Advanced Magnetics’ president and CEO.