The purpose of this study is to confirm the non-inferiority of Z-213 compared to Saccharated Ferric Oxide using the maximum change in Hb from baseline over 12 weeks in patients with Iron-deficiency Anemia (IDA)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
238
The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed)
The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV two or three times per week
Unnamed facility
Tokyo, Japan
Maximum change in Hb value
Time frame: 12 weeks
Change in Hb value
Time frame: 12 weeks
Proportion of responders
Time frame: 12 weeks
Proportion of subjects with normalization in Hb value
Time frame: 12 weeks
Proportion of cumulative dosage
Time frame: 12 weeks
Dosing period and the number of doses
Time frame: 12 weeks
Incidence of Adverse Events
Time frame: 12 weeks
Incidence of Adverse Drug Reactions
Time frame: 12 weeks
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