Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa

Inclusion Criteria:

• Patients with end stage renal disease (stage CKD 5d), receiving stable subcutaneousmaintenance therapy with Epogen® or Procrit® at least once per week

• Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period

• Adequate iron substitution

Exclusion Criteria:

• Contraindications for Erythropoiesis Stimulating Agent (ESA) therapy

• History of Pure Red Cell Aplasia (PRCA), or anti-erythropoietin (EPO) antibodies

• Known Human Immunodeficiency Virus (HIV) or Hepatitis B infection

• Hepatitis C infection on an active treatment

• Symptomatic congestive heart failure (New York Heart Association [NYHA] class III andIV)

• Unstable angina pectoris, or cardiac infarction during the last 6 months prior torandomization

• Percutaneous coronary intervention, or coronary artery bypass grafting during the last 6 months prior to randomization

• History of malignancy of any organ system

• Systemic lupus erythematous

• Immunocompromized patients Other In-/Exclusion criteria may apply