Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients

Inclusion Criteria: * Known chronic renal insufficiency of at least 4 weeks duration; CKD stage at least 3 or higher * Male and female patients, age: \>=18 * Patients who are naïve to ESA treatment or previously ESA treated after 3 months of ESA-free period (i.v. or s.c.) * Patients with symptomatic anemia, defined as Hb level below 11.0 g/dL and not lower than or equal to 7.5 g/dL on at least 2 visits during the screening period * Adequate iron status, serum ferritin \>= 100 µg/L or transferrin saturation \>= 20% * Ability to follow study instructions and likely to complete all required visits and compliant with subcutaneous administration * Written informed consent of the patient. Exclusion Criteria: * Anemia of non-renal causes * Therapy with immunosuppressants (other than corticosteroids for chronic treatment) within 3 months before screening and during the study for patients with renal allograft in place or other chronic conditions (e.g. lupus erythematosus, rheumatic arthritis) * Patients previously treated with chronic dialysis within the last 6 months (exception: one session of acute dialysis) * Patients with acute deterioration of renal function during the screening phase according to the investigator's judgment * Patients receiving any RBC/whole blood transfusion during the screening period * Primary hematological disorder (e.g. myeloma, myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia) * Evidence of uncontrolled diabetes m…