Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)

Inclusion Criteria: * Male and female subjects between the age of 18 to 75 years * Subjects with end stage renal disease (CKD stage 5) on hemodialysis and on epoetin treatment for at least 3 months prior to screening * Subjects with haemoglobin between 10 g/dl to 12 g/dl * Subjects who are on clinically stable haemodialysis (defined as no clinically relevant changes of dialysis regimen and/or dialyzer) for at least 3 months prior to screening * Subjects willing to provide a written informed consent * Subjects with serum ferritin ≥ 200 μg/L and/or transferrin saturation ≥ 20% * Subjects with a life expectancy of more than at least study period in clinical judgment of the investigator Exclusion Criteria: * Subjects with anaemia due to other reasons (that is not renal anaemia) * Subjects who have undergone blood transfusion within the last 3 months * Subjects with major complication such as severe/chronic infections or bleeding or aluminum toxicity * Subjects with suspected or known pure red cell aplasia (PRCA) * Subjects with a history of aplastic anaemia * Subjects with uncontrolled diabetes (fasting blood glucose \> 240 mg/dl) or uncontrolled hypertension (systolic blood pressure \> 180 mm Hg, diastolic blood pressure \> 110 mm Hg) * Subjects with known hypersensitivity to any of the ingredients of the investigational products, the mammalian cell-derived product or human albumin products * Subjects with history of seizure disorder * Subjects with hematological disorder * S…