Anemia of Chronic Kidney Disease Clinical Trial
Official title:
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluation the Efficacy and Safety of Intravenous CKD-11101 Versus Darbepoetin Alfa in Patients Who Had Renal Anemia Receiving Hemodialysis
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.
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