By Kasia Michalik
When kidneys fail, the production of erythropoietin, the hormone that drives the production of red blood cells, stops. As a result, patients are provided with dialysis and an erythropoietin-stimulating agent (ESA). During each dialysis session, a patient loses anywhere from five to seven milligrams of iron and becomes iron deficient causing anemia.
Rockwell Medical, a biopharmaceutical company that focuses on end-stage renal disease (ESRD), chronic kidney disease (CKD) and iron deficiency, discussed the alternative iron therapy for dialysis patients, Soluble Ferric Pyrophosphate (SFP) during the annual American Society of Nephrology (ASN) Kidney Week that took place in San Diego from October 31 to November 4.
Originally the study into SFP began in the late 1990s. It was first published in 1999 in Kidney International. The single-center study took place in a hospital in Detroit and it took patients in one group on regular dialysis and the other group with a dose of SFP.
The study is now in its final phase 3. It will be complete in July/August 2013 and data will be released around November of 2013, pending approval from the U.S. Food and Drug Administration (FDA).
How it Works
The way a normal person receives iron is through food. When iron enters the body it looks for the transferrin so the iron can be taken to the bone marrow. During the same time, the healthy kidneys are producing erythropoietin, which also travels to the bone marrow. The combination of those two things creates red blood cells.
SFP mimics that, but it doesn't enter through food. It enters through a dialysate. Three times a week, when a patients is receiving dialysis, SFP crosses the membrane, immediately binds with the transferrin and takes it to the bone marrow.
Because a patient on dialysis doesn't have function of the kidneys they are receiving a dose of Epogen or Omontys.