This was an open-label, randomized, active drug-comparative, parallel-designed, multi-center study in hemodialysis patients with anemia.~This study consisted of a screening period (4 weeks), titration period (4~8 weeks) baseline evaluation period (4 weeks), maintenance period (24 weeks), and 4 weeks for the evaluation period. Patients who were eligible in the screening period underwent the titration period. The reference product at an individualized dose 3 times a week through intravenous injection was given and the hemoglobin (Hb) level of the subject was controlled to reach the target range of 10-12 g/dL in the titration period. In the maintenance period, the subjects were randomized and administered with reference product or test product that was done with the same doses regimen during the titration period through intravenous injection. The primary endpoints of efficacy evaluation were to demonstrate that treatment of test product was equivalence with the reference product by evaluating Hb level change between baseline (Week 5-8/9-12) and evaluation period (Week 33-36/37-40), while the secondary endpoints were to obtain data mean change in weekly dosage per kg body weight between the baseline period and the evaluation period, to calculate instability rate of Hb level during maintenance and evaluation period as defined when Hb level dropped below 8 g/dL or increased by more than 13 g/dL and to evaluate the Hb and hematocrit (Ht) level during maintenance and evaluation period. The safety evaluation was conducted based on the incidence of the adverse events of both local and systemic reactions.
The 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.