Lead Sponsor

Sandoz

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•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

•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