This study is a multicenter, prospective, randomized phase 3 clinical study comparing the efficacy and safety of the combination treatment of ESA and high-dose IV iron (darbepoietin alfa + ferric derisomaltose/iron isomaltoside) with ESA monotherapy (darbepoietin alfa alone) in CIA patients with functional iron deficiency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
312
Ferric derisomaltose/iron isomaltoside (as iron) (0 weeks): 20mg/kg, diluted in 250ml of 0.9% physiological saline and injected intravenously over 30-60 minutes
Darbepoietin alfa (0 weeks, 3 weeks, 6 weeks, 9 weeks): 6.75㎍/kg, subcutaneous or intravenous administration
Hallym University Medical Center
Anyang-si, South Korea
RECRUITINGMean Hb change
Mean change in Hb concentration from baseline to 12 weeks
Time frame: from baseline to 12 weeks
Hemoglobin response
defined as an increase in Hb level of 2.0g/dL≥ from baseline value during 12-week study period
Time frame: during 12-week study period
Time to hemoglobin response
Time frame: during 12-week study period
Proportion of patients requiring RBC transfusion during 12-week study period
Time frame: during 12-week study period
Quality of life assessment by Functional Assessment of Cancer Therapy-Anemia (FACT-An)/health-related quality of life instrument with 8 items (HINT-8)/EQ-5D-5L
Time frame: during 12-week study period
Safety analysis
Adverse events including AE of special interst (Anaphylaxis, Infusion reaction, Thromboembolic event)
Time frame: during 12-week study period
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