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 mellitus (HbA1c \> 10 % at visit -2) * Evidence of severe hepatic dysfunction (e.g. ALT and/or AST above 2x upper limit of normal range; or gamma-GT above 3x upper limit of normal range) * Clinical evidence of current uncontrolled or symptomatic hyperparathyroidism, defined as parathyroid hormone \> 500 ng/L at visit -2. * Uncontrolled hypertension, defined as a systolic blood pressure of \>= 160 mmHg and a diastolic blood pressure measurement \>= 100 mmHg (average of two values with at least one day between measurements) * Congestive heart failure and/or angina pectoris \[New York Heart Association (NYHA) class III and IV\] * History of stroke or myocardial infarction during the last 6 months prior to visit -2 * Ongoing treatment with phenprocoumon or other cumarin derivates * Thrombocytopenia (platelet count \<100.000/µL) or leucopenia (white blood cell count \< 2.000/µL) * Gastrointestinal bleeding within the last 6 months prior to visit -2 or hemolysis * Evidence of acute or chronic infection by a C-reactive protein value of \> 30 mg/L * Suspicion or known PRCA (pure red cell aplasia) * Previously diagnosed HIV or acute hepatitis infection * History of epilepsy or epileptic seizures or treatment for epilepsy within the past 6 months prior to screening * Planned major surgery (with expected high blood loss) during the next 3 months or major surgery within the previous 3 months (except laser photocoagulation, access surgery) * Clinical evidence of active malignant diseases within the last 5 years (except non-melanoma skin cancer) * Pregnancy, breastfeeding women or women not using a highly effective birth control method (e.g. implants, injectables, combined oral contraceptives, IUD, sexual abstinence, vasectomised partner) * Known history of severe drug related allergies (e.g. anaphylactic shock) * Known allergy to one of the ingredients of the test product or hypersensitivity to mammalian-derived products * Known or suspicion of any non-compliance with respect to subcutaneous treatment * Simultaneous participation in another clinical study or participation in a study in the month preceding visit-2 or previously randomized in this study * Participation in another ESA study in the 3 months preceding visit -2 * Any other condition which at the investigator's discretion may put the patient at risk or which may confound the study results.