HEMATOCRIT Trial: A randomised controlled trial of oral HEMe iron polypeptide Against Treatment with Oral Controlled Release Iron Tablets for the correction of anaemia in peritoneal dialysis patients

Heme iron polypeptide (HIP) (Proferrin ES [registered trademark], Colorado Biolabs, USA) is approved for use as a dietary/nutritional supplement in Canada and the United States of America. The usual dose is 1 tablet (equivalent to 12 mg elemental iron) taken twice or thrice daily, either with or without food. The side effects reported with HIP are similar to those associated with conventional oral iron preparations and include nausea, vomiting and constipation. However, trials in healthy individuals and in haemodialysis patients suggest that the incidence of such adverse drug reactions is relatively low, possibly due to the different absorption characteristics of heme versus non-heme iron. For example, in a study of 37 haemodialysis patients receiving HIP for 6 months, constipation occurred in 3 (8%) patients and was the only observed adverse effect of the agent. The dose of HIP used in that investigation (3 tablets per day) was 50% higher than that proposed in the present study (2 tablets per day). There are no other published data concerning the side effect profile of HIP in end-stage renal failure patients. Concern has previously been expressed about the possibility of transmission of bovine spongiform encephalopathy (BSE) through the consumption of bovine tissue. Currently, HIP is manufactured from red blood cells of cows of American origin, and both the US Department of Agriculture and Food and Drug Administration (FDA) currently maintain that the United States is free of BSE. In addition, the putative infectious agents for BSE, conformationally shifted neuronal membrane copper-binding proteins called prions, usually are not found in blood. Thus, the risk of BSE from taking HIP is negligible. In thus study, the Proferrin will be taken by patients for a period of 6 months.