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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
207
Recombinant human erythropoietin falls under the pharmacological class of haematopoietic / anti anaemic agents. It has been developed for the treatment of anaemia in subjects with chronic kidney disease. Erythropoietin, also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or RBC production. It is a cytokine (protein signalling molecule) for erythrocyte precursors in the bone marrow. Human EPO has a molecular weight of 34,000.
Recombinant human erythropoietin falls under the pharmacological class of haematopoietic / anti anaemic agents. It has been developed for the treatment of anaemia in subjects with chronic kidney disease. Erythropoietin, also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or RBC production. It is a cytokine (protein signalling molecule) for erythrocyte precursors in the bone marrow. Human EPO has a molecular weight of 34,000.
Mean absolute change in haemoglobin level from baseline to 6 months
Mean absolute change in haemoglobin level from baseline to 6 months after treatment with EPIAO/EPREX in parallel groups (g/dl).
Time frame: from baseline to 6 months
Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 6 months
Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 6 months after treatment with EPIAO/EPREX in parallel groups (IU/kg/week).
Time frame: from baseline to 6 months
Mean absolute change in haemoglobin level from baseline to 9 months
Mean absolute change in haemoglobin level from baseline to 9 months after treatment with EPIAO/EPREX in parallel groups (g/dl).
Time frame: from baseline to 9 months
Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 9 months
Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 9 months after treatment with EPIAO/EPREX in parallel groups (IU/kg/week).
Time frame: from baseline to 9 months
Proportion of subjects with hemoglobin values are within 10 - 12 g/dl
Proportion of subjects with hemoglobin values are within 10 - 12 g/dl for the last 4 weeks of the period for assessment of treatment of efficacy and safety (weeks 32-36)
Time frame: weeks 32-36
Incidence of blood transfusions
Incidence of blood transfusions
Time frame: 52 weak
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...and 9 more locations