Iron is critical for normal hemoglobin synthesis to maintain oxygen transport. Additionally, iron is necessary for metabolism and synthesis of DNA and various enzymatic processes. The total body iron content of an adult ranges from 2 to 4 grams. The administration of exogenous erythropoietin increases red blood cell production and iron utilization. The increased iron utilization and blood losses in the hemodialysis patient may lead to absolute or functional iron deficiency.
Iron deficiency is absolute when hematologic indicators of iron stores are low.
The study included both a dose-response concurrent control and an historical control. The primary endpoint was the change in hemoglobin from baseline to the last available observation through Day 40. Parenteral iron and red cell transfusion were not allowed for two months before the study. Oral iron and red cell transfusion were not allowed during the study for Ferrlecit -treated patients. The historical control population consisted of 25 chronic hemodialysis patients who received only oral iron supplementation for 14 months and did not receive red cell transfusion.