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Rockwell Medical's protocol approved for study of IV iron delivery replacement in hemodialysis
By Lisa Kerner
Charlotte, N.C., July 20 - Rockwell Medical Technologies, Inc. said the Western Institutional Review Board has approved its protocol to study the advantages of soluble ferric pyrophosphate delivery via dialysate in hemodialysis patients.
The nine-month National Institutes of Health-sponsored study is expected to begin in the third quarter of 2006, according to a company news release.
Early clinical studies showed that compared to intravenous iron administration, delivering iron via dialysate safely maintains iron balance in dialysis patients, while eliminating nursing and pharmaceutical IV iron administration costs.
The company said it is seeking Food and Drug Administration approval to market the product in the $400 million U.S. IV-iron delivery dialysis market.
Located in Wixom, Mich., Rockwell is a manufacturer and developer of specialty pharmaceuticals for dialysis patients.
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