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 subcutaneous
maintenance 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 and
IV)

- Unstable angina pectoris, or cardiac infarction during the last 6 months prior to
randomization

- 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