• Mean change in Hgb between baseline and the Evaluation Period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  

• Proportion of patients who receive red blood cell (RBC) transfusions during the Titration and Evaluation Periods. Proportion of patients whose mean Hgb level during the Evaluation Period is within the target range of 10.0 - 12.0 g/dL [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  

Anemia of chronic renal failure is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors also include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The prevalence of anemia increases with progressive deterioration of renal function, and affects more than 90% of patients with CKD Stage 5 (End Stage Renal Disease). Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function and exercise capacity, increased left ventricular hypertrophy and heart failure. Treatment of anemia reduces morbidity and mortality risks and may improve quality of life. Therefore, anemia should be diagnosed and treated early.

Erythropoiesis stimulating agents have been established as a treatment for anemia in chronic renal failure subjects, and have improved the management of anemia over alternatives such as transfusion. Hematide is a parenteral formulation being developed for the correction of anemia in patients with chronic renal failure, and binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents.

Subjects participating in this study will receive Hematide once every 4 weeks or Epoetin alfa 1-3 times per week. Total commitment time of this study is a minimum of 52 weeks of study treatment.