The aim of this study was to compare and evaluate efficacy and safety of subcutaneous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia not on dialysis.
This was designed as randomized, double-blind, multi-center, Phase 3 clinical study to evaluate the efficacy and safety of subcutaneous CKD-11101 versus Darbepoetin Alfa in patients who had stage 3, stage 4, and stage 5 chronic renal failure not on hemodialysis or peritoneal dialysis. The selection criteria will be evaluated in patients who are receiving anemia correction among patients with 19 years of age or older and who had anemia in chronic renal failure of stage 3 or above. Subjects who are identified to meet all inclusion criteria will be randomized to test group and control group at 1:1 ratio and go through 24-week correction period and efficacy evaluation period. During correction period and efficacy evaluation period, subjects will visit the clinical study center every 2 weeks to receive processes designated for each visit and be administered investigational product from the investigator in charge of drug administration. In the safety evaluation period, all subjects will be administered test drug for 28weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
248
Changed amount of mean hemoglobin level in evaluation period compared to the baseline
The equivalence test on mean hemoglobin level of test drug and reference drug administration groups in evaluation period (Weeks 20 - 24) compared to the baseline (Week 0) will be conducted.
Time frame: ([Mean of hemoglobin measured in Weeks 20 - 24] - [Hemoglobin measured at Week 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 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
Ratio of subjects who achieve target level of hemoglobin: Compare the number of subjects who achieve target level of hemoglobin during the evaluation period between groups
Time frame: Weeks 20 - 24
Days taken to reach target level of hemoglobin
Days taken to achieve target level of hemoglobin: Compare days taken to achieve target level of hemoglobin between groups
Time frame: Days taken to reach up to 24 weeks
Mean hemoglobin level for each week
Mean hemoglobin level for each week: Compare Weeks 4, 8, 12, 16, 20, 24, and 52 between groups
Time frame: Weeks 4, 8, 12, 16, 20, 24, and 52
Changed amount of mean hemoglobin level at Weeks 20, 24, and 52 compared to the baseline
Compare the mean change of hemoglobin level at Weeks 20, 24, and 52 compared to the baseline
Time frame: Weeks 20, 24, and 52
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Ratio of subjects who receive transfusion
Ratio of subjects who receive red blood cell transfusion: Compare ratio of subjects who receive red blood cell transfusion during treatment period and evaluation period between groups
Time frame: Weeks 0 - 24