Biosimilar Erythropoietin in Anaemia Treatment (Correction Phase Study)

A Prospective, Randomized, Double Blind, Parallel Group Study to Establish the Therapeutic Equivalence of EPIAO® With the Standard Treatment EPREX® in Subjects With Chronic Kidney Disease (CKD) Related Anaemia Not Yet on Dialysis

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.

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