Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients

Inclusion Criteria

• Receiving dialysis for at least 6 months (3 times weekly) before screening
• Age: >=18
• Clinically stable, i.e. hemoglobin within the established range (10.0 to 13.0 g/dl) for at least 12 weeks before screening
• Stable intravenous dosage of ERYPO® three times weekly for at least 8 weeks before screening and during screening with a maximal weekly dosage of 300 IU/kg body weight (stable is defined as =100 µg/l and/or saturated transferrin levels >=20%
• C-reactive protein = 5 mg/l =10mg/l =100 mg/l: +++)
• Ability to follow study instructions and likely to complete all required visits
• Written informed consent of the patient

Exclusion Criteria

• Anemia of non-renal causes
• Primary hematologic disorder (e.g. myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia)
• Evidence of severe hepatic dysfunction (ALT and/or AST above 2 x upper limit of normal range; or gamma-GT above 3 x upper limit of normal range)
• Clinical evidence of current uncontrolled hyperparathyroidism (serum parathyroid hormone >1500 pg/mL).
• Known history of bone marrow disease
• Any red blood cell transfusion(s) during the last 12 weeks before screening or during the screening/baseline period
• Insufficient concomitant iron treatment during the last 2 months before Visit -2
• Uncontrolled hypertension, defined as a predialysis diastolic blood pressure measurement >=110 mmHg during the screening period
• Congestive heart failure [New York Heart Association (NYHA) class III and IV]
• Unstable angina pectoris, active cardiac disease, cardiac infarction during the last six months before screening
• History of blood coagulation disease
• Thrombocytopenia (platelet count <100.000/µl)
• Leukopenia (white blood cell count < 2.000/µl)
• Overt bleeding (acute or chronic bleeding within 2 months of inclusion) or hemolysis
• Evidence of acute infectious disease or serious active inflammatory states within one months before screening (Visit -2) or during the screening/baseline period
• Suspicion or known PRCA (pure red cell aplasia)
• Previously diagnosed HIV or acute hepatitis infection
• Treatment for epilepsy within the past 6 months
• Planned surgery during the next 7 months (except vascular access surgery)
• Any androgen therapy within 2 months before visit -2 and during the study
• Therapy with immunosuppressants or any drug known to affect the hematocrit within 1 month before Visit -2 and during the study
• Clinical evidence of malignant diseases
• Pregnancy, breastfeeding women or women not using adequate birth control measures
• Known history of severe drug related allergies
• Known allergy to one of the ingredients of the test or reference products or hypersensitivity to mammalian-derived products
• Simultaneous participation in another clinical study or participation in a study in the month preceding the start of this study or previously randomized in this study
• Participation in an erythropoietin study in the 3 months preceding screening (visit -2)
• Any other condition which at the investigator´s discretion may put the patient at risk or which may confound the study results