Abstract
Purpose This study was conducted to evaluate whether the efficacy and
safety profile of recombinant human erythropoietin (rhEPO) manufactured by
Daewoong Pharmaceutical Co., Ltd was similar to biological products approved by
the drug safety regulatory authority.
Patients and methods It was an open-label, randomized, comparative,
parallel, multi-center study in hemodialysis patients with anemia. The reference
product at an individualized dose 3 times a week was given in 4–8 weeks
of titration period and hemoglobin (Hb) level was controlled to reach the range
of 10–12 g/dL. Then, the subjects were randomly
administered with reference or test product with the same dose regimen. The
primary endpoints were to demonstrate the Hb level change between baseline and
evaluation period in both treatment groups, while the secondary endpoints were
the mean change in weekly dosage per kg body weight and the instability rate of
Hb level during maintenance and evaluation period. The safety was evaluated
based on the adverse events incidence.
Results There was no statistical difference in the change of Hb between
test and reference (0.14 g/dL and 0.75 g/dL
respectively, with p>0.05), also for the mean changes of weekly dosage
between groups (1091.40 IU and 570.15 IU respectively, with p>0.05). The
instability rate of Hb in both test and reference was not statistically
significantly different as well (26 and 15% respectively, with
p>0.05).
Conclusion This study proves that the efficacy indicated by the change
instability of Hb and safety indicated by adverse event incidence of Epodion and
the reference product on chronic kidney disease were similar.
Keywords
comparative - erythropoietin - CKD - Anemia
