Positive results from a Phase III clinical trial of ferumoxytol as an intravenous (IV) iron replacement therapeutic has recently been announced by Advanced Magnetics (Nasdaq: AMAG) and presented at the American Society of Nephrology's Renal Week 2006 Annual Meeting in San Diego, CA via a poster entitled "Ferumoxytol as Intravenous Iron Replacement Therapy in Chronic Kidney Disease (CKD) Patients Not on Dialysis -- Evaluation of Safety and Efficacy in Two Phase III Studies" (a pdf file).
The study revealed a statistically significant achievement of all the primary and secondary endpoints. In addition, all primary and secondary endpoints were statistically significant in both patients on erythropoiesis stimulating proteins (ESP) and those not on ESPs.
Find more details from the press release.
The Phase III Clinical trial was a randomized study of 304 non dialysis-dependent chronic kidney disease patients (NDD-CKD) who receive either two 510 mg doses of ferumoxytol within one week or 200 mg of oral iron daily for three weeks.
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