CKD-11101 Phase 3 SC Study

Phase 3

Completed

Interventions: Biological: CKD-11101(Darbepoetin alfa)
Biological: NESP(Darbepoetin alfa)

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
CKD-11101(Darbepoetin alfa)	CKD-11101(Darbepoetin alfa)	The dose of investigational product (Darbepoetin alfa) is adjusted according to the principles reflecting the MFDS (Ministry of Food and Drug Safety) approval for NESP, but is determined by the investigator's judgment considering various factors of the subjects that may affect the treatment of anemia.
NESP(Darbepoetin alfa)	NESP(Darbepoetin alfa)	The dose of investigational product (Darbepoetin alfa) is adjusted according to the principles reflecting the MFDS (Ministry of Food and Drug Safety) approval for NESP, but is determined by the investigator's judgment considering various factors of the subjects that may affect the treatment of anemia.

Primary Outcome Measures

Name	Time	Method
Changed amount of mean hemoglobin level in evaluation period compared to the baseline	([Mean of hemoglobin measured in Weeks 20 - 24] - [Hemoglobin measured at Week 0])	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.
Mean administration dose in evaluation period: Mean dose administered in Weeks 20 - 24	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.

Secondary Outcome Measures

Name	Time	Method
Days taken to reach target level of hemoglobin	Days taken to reach up to 24 weeks	Days taken to achieve target level of hemoglobin: Compare days taken to achieve target level of hemoglobin between groups
Mean hemoglobin level for each week	Weeks 4, 8, 12, 16, 20, 24, and 52	Mean hemoglobin level for each week: Compare Weeks 4, 8, 12, 16, 20, 24, and 52 between groups
Ratio of subjects who achieve target level of hemoglobin	Weeks 20 - 24	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
Changed amount of mean hemoglobin level at Weeks 20, 24, and 52 compared to the baseline	Weeks 20, 24, and 52	Compare the mean change of hemoglobin level at Weeks 20, 24, and 52 compared to the baseline
Ratio of subjects who receive transfusion	Weeks 0 - 24	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