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

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.