HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)

Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of HX575 Epoetin Alfa in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Patients

The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)

Main Inclusion Criteria:

• Adult male and female patients w or w/o dialysis treatment
• Stable i.v. or s.c. maintenance therapy with an EU-approved ESA treatment or ESA naïve.
• Adequate iron substitution

Main Exclusion Criteria:

• History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies
• Contraindications for ESA therapy
• Serum albumin < 3.0 g/dL
• Immunocompromized patients (immunosuppressive treatment, chemotherapy)
• Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency virus (HIV) infection
• Systemic lupus erythematosus
• Symptomatic congestive heart failure, Unstable angina pectoris, or myocardial infarction within 6 months
• History of malignancy of any organ system within the last 5 years
• History of use of any non-EU approved ESA