biosimilar erythropoietin in anaemia treatment (correction phase study)

Conditions: Renal Anaemia

Summary: this study is aimed to comprehensively establish the biosimilarity/bioquivalence in epiao® and eprex® in terms of 52-week comparisons in efficacy,safety and immunogenicity.the targeted population is anaemia patients with chronic renal disease who are naive to epoetin treatment and not yet 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 not yet on dialysis (pre-dialysis). a total of 96 subjects will be randomized into two groups in a 1:1ratio. treatment arm a will receive epiao® once a week, subcutaneously for period of 52 weeks and treatment arm b will receive eprex, weight once a week, subcutaneously for period of 52 weeks.

Eligibility criteria:
inclusion criteria: 1. male and female subjects between the age of 18 to 75 years 2. subjects with renal anaemia (haemoglobin 7.5 g/dl to 10 g/dl) 3. subjects who are treatment naïve to epoetin 4. subjects with chronic kidney disease (ckd) stages\* 3 and 4 not yet on dialysis (predialysis) 5. subjects willing to provide a written informed consent 6. subjects with serum ferritin ≥ 100 μg/l and/or transferrin saturation ≥ 20% * ckd staging will be based on the five-stage system for classification of ckd based on kdigo guidelines. exclusion criteria: 1. subjects with anaemia due to other reasons (that is not renal anaemia) 2. subjects on dialysis 3. subjects who have undergone blood transfusion within the last 3 months 4. subjects with major complication such as severe/chronic infections or bleeding, or aluminum toxicity 5. subjects with suspected or known prca 6. subjects with a history of aplastic anaemia 7. 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) 8. subjects with known hypersensitivity to any of the ingredients of the investigational products, the mammalian cell-derived product or human albumin products 9. subjects with history of seizure disorder 10. subjects with hematological disorder (thrombocytopenia, neutropenia, or hemolysis) 11. subjects with hyperparathyroidism (intact parathyroid hormone \> 1000 pg/ml) 12. subjects with severe liver dysfunction 13. subjects with congestive heart failure and/or angina (nyha class iii and iv) 14. subjects with myocardial infarction or stroke in the preceding 6 months of screening 15. subjects with active malignancy in the previous 5 years 16. subjects with gastrointestinal bleeding in the past 6 months 17. subjects with immunosuppressive therapy in the previous 3 months 18. subjects with hepatitis b virus (hbsag), hepatitis c virus (hcv), human immunodeficiency virus (hiv) and syphilis 19. 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 20. subjects participating in trials involving erythropoietin in the past 6 months before screening 21. subjects currently participating or participation in an investigational study within 30 days prior screening

Keywords: biosimilar epoetin efficacy safety immunogenicity renal anaemia