Anemia of Chronic Kidney Disease Clinical Trial
Official title:
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Subcutaneous CKD-11101 Versus Darbepoetin Alfa in Patients Who Had Renal Anemia Not on Dialysis
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.
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