biosimilar erythropoietin in anaemia treatment (maintenance phase study)

Conditions: Renal Anemia

Summary: 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.

Eligibility criteria:
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

Keywords: renal anemia haemodialysis maintenance phase