By Thomas S. May
TORONTO -- June 4, 2008 -- Ferumoxytol, an investigational IV agent awaiting approval in the United States, is superior to conventional oral iron replacement therapy for treatment of anaemia in kidney transplant recipients, a subanalysis of 2 randomised controlled studies shows.
Results of the subanalysis were presented here on May 31 in a poster session at the 2008 American Transplant Congress (ATC), by Daniel W. Coyne, MD, Washington University School of Medicine, St. Louis, Missouri.
"Anaemia in kidney transplant recipients is common, and iron deficiency is a common cause or contributor," Dr. Coyne said. "These patients are on multiple medications, and the addition of oral iron has significant side effects and is usually not effective," he explained.
Dr. Coyne noted that other IV iron products require long infusions or several injections over many days.
In the present study, data were pooled from 2 randomised, controlled, open-label, phase 3 trials that evaluated the efficacy and safety of ferumoxytol versus elemental iron in patients with chronic kidney disease. Patients received either 200 mg of oral elemental iron every day for 21 days, or 2 doses of IV ferumoxytol 510 mg given in 53 days. Subjects from a phase 2 and an additional phase 3 trial were also included to assess safety.
The scientists analysed data from a subpopulation of 31 patients who were included in the 2 randomised, phase 3 trials, plus an additional 11 patients who participated in the 2 safety studies.
Regarding efficacy, the researchers found that ferumoxytol increased mean haemoglobin levels by 1.39 g/dL, whereas oral iron resulted in a mean decrease of 0.16 g/dL in haemoglobin levels (P = .035 for difference between means).
According to the researchers, the incidence of adverse events in subjects receiving ferumoxytol was at least as good as what has been seen in patients receiving elemental oral iron.
"This study showed that ferumoxytol could effectively and safely treat iron deficiency in kidney transplant recipients when given as 2 injections, a day or more apart," said Dr. Coyne. "We've also found that oral iron was ineffective, and many patients had side effects," he added.
Funding for this study was provided by AMAG Pharmaceuticals.
[Presentation title: Ferumoxytol as an Intravenous Iron Replacement Therapy: Efficacy and Safety in Subjects With Functioning Kidney Transplants. Abstract 687]
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