Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)

A Prospective, Randomized, Double Blind, Parallel Group Study to Evaluate a 1:1 Dose Conversion From EPREX to EPIAO in Term of Clinical Efficacy and Safety in Subjects With End-Stage Renal Disease on Haemodialysis

This study is aimed to comprehensively establish the bio-similarity/bioequivalence in EPIAO® and EPREX® in terms of 52-week comparisons in efficacy, safety and immunogenicity. The targeted population is anaemia patients with end-stage chronic renal disease who previously received epoetin treatment and on haemodialysis.

This is a prospective, randomized, double blind, parallel group two arm study to establish the therapeutic equivalence, safety and tolerability of EPIAO® as compared to EPREX® in the treatment of CKD related anaemia in subjects who are on haemodialysis. A total of 264 subjects will be randomized into two groups in a 1:1 ratio. Treatment arm A will receive EPIAO® 1-3 times a week, intravenously for period of 52 weeks and treatment arm B will receive EPREX, 1-3 times a week, intravenously for period of 52 weeks.

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
• Subjects with hyperparathyroidism
• Subjects with congestive heart failure and/or angina (NYHA class III and IV)
• Subjects with myocardial infarction or stroke in the preceding 6 months of screening
• Subjects with active malignancy in the previous 5 years
• Subjects with gastrointestinal bleeding in the past 6 months
• Subjects with immunosuppressive therapy in the previous 3 months
• Subjects with active hepatitis B virus (HBsAg) (positive for HBsAg and IgM anti-HBc) and hepatitis C virus (HCV) (positive for Anti-HCV antibody) and human immunodeficiency virus (HIV)
• Female subjects who are pregnant, breast-feeding, planning to be pregnant during the study, or women of child-bearing potential (any woman who is not surgically sterile i.e. bilateral tubal ligation, total hysterectomy or < 2 years post menopause) not using a reliable method of double contraception (e.g. condom plus diaphragm, condom or diaphragm plus spermicidal gel/foam, tubal ligation, or stable dose of hormonal contraception) throughout the study period
• Subjects participating in trials involving erythropoietin in the past 6 months before screening.Subjects currently participating or participation in an investigational study within 30 days prior screening