The Clinical Study for Evaluating The Safety And Efficacy Of Epodion®
Condition: Chronic Kidney Disease (CKD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Recombinant Human Erythropoietin Alpha; Recombinant Human Erythropoietin Alpha
Intervention type(s): Biological; Biological
Intervention description(s): 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; 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
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open-label, randomized, active drug-comparative, parallel-designed
Masking: None (Open Label)
Primary purpose: Treatment