ACCESSRandomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of HX575 Epoetin Alfa vs. US Licensed Epoetin Alfa (Epogen®/Procrit®) in the Treatment of Anemia Associated With Chronic Kidney Disease

Fecha de inicio: 1 de septiembre de 2012

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