The aim of this study was to compare and evaluate efficacy and safety of intravenous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia receiving hemodialysis.
This study was designed as randomized, double-blind, multi-center, Phase 3 clinical study to evaluate the efficacy and safety of intravenous CKD-11101 versus Darbepoetin alfa in patients who had renal anemia receiving hemodialysis. The selection criteria are evaluated for 19-year-old patients who receive stable hemodialysis treatment for 3 months or more in patients with chronic renal failure. After completion of the stabilization period of 12 to 16 weeks for Darbepoetin Alfa, the subjects with the mean Hb levels of 10 to 12g/dl measured during the baseline visit and 0 week visit are randomized to the test and control groups in a 1:1 ratio during the randomization visit. They have a 20-week maintenance period and a 4-week evaluation period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
403
Changed amount of mean hemoglobin level in evaluation period compared to the baseline
The equivalence test on mean hemoglobin level of test drug and to Reference Drug administration groups in evaluation period (Weeks 20 - 24) compared to the baseline (Weeks -4 - 0) will be conducted.
Time frame: ([Mean of hemoglobin level measured in Weeks 20 - 24] - [Mean of hemoglobin level measured at Weeks -4 - 0])
Mean administration dose in evaluation period: Mean dose administered in Weeks 20 - 24
The equivalence test on mean administration dose of test drug and to Reference Drug administration groups in evaluation period (Weeks 20 - 24) will be conducted.
Time frame: Weeks 20 - 24
Ratio of subjects who achieve target level of hemoglobin during the evaluation period
Ratio of subjects who maintain target level of hemoglobin: Compare the number of subjects who do not deviate from target level of hemoglobin during the evaluation period between groups
Time frame: Weeks 20 - 24
Mean hemoglobin levels at Weeks 20 and 24
Mean hemoglobin level at Weeks 20 and 24: Compare mean hemoglobin level at Weeks 20 and 24 between groups
Time frame: Weeks 20, 24
Ratio of subjects who maintain hemoglobin level ≥ 10g/dl during maintenance period and evaluation period (interval of every 2 weeks)
Compare ratio of subjects who maintain hemoglobin level ≥ 10g/dl during maintenance period and evaluation period between groups (interval of every 2 weeks)
Time frame: Weeks 0 - 24
Ratio of subjects who changed dose during maintenance period and evaluation period
Ratio of subjects who changed dose: Compare ratio of subjects who change dose during maintenance period and evaluation period between groups
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Time frame: Weeks 0 - 24
Ratio of subjects who receive transfusion during maintenance period and evaluation period
Ratio of subjects who receive red blood cell transfusion: Compare ratio of subjects who receive red blood cell transfusion during maintenance period and evaluation period between groups
Time frame: Weeks 0 - 24
Number of red blood cell transfusion per subject during maintenance period and evaluation period
Number of red blood cell transfusion per subject: Compare number of red blood cell transfusion per subject during maintenance period and evaluation period between groups
Time frame: Weeks 0 - 24