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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
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.
Bamrasnaradura Infectious Disease Institute
Bangkok, Thailand
Bhumibol Adulyadej hospital
Bangkok, Thailand
BMA hospital
Bangkok, Thailand
Chulalongkorn King Memorial hospital
Bangkok, Thailand
Mean absolute change in haemoglobin(Hb)
Mean absolute change in haemoglobin(Hb) level from baseline to 24 weeks after treatment with EPIAO®/EPREX® in parallel groups (g/dl),respectively."
Time frame: 24 weeks
Mean absolute change in weekly epoetin dosage
Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 24 weeks after treatment with EPIAO®/EPREX® in parallel groups (IU/kg/week).
Time frame: 24 weeks
Frequency of adverse events
To observe the frequency of adverse events following EPIAO® and EPREX® administration.
Time frame: 52 weeks
Occurence of anti-epoetin antibodies
To monitor the occurrence of anti-epoetin antibodies among subjects following at least 52 weeks of therapy.
Time frame: 52 weeks
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Klongton Hospital
Bangkok, Thailand
Phramongkutklao hospital
Bangkok, Thailand
Rajavithi hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand