Iron Deficiency Anemia Clinical Trial
Official title:
A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) and Iron Sucrose in Subjects With Iron Deficiency Anemia (FERWON-IDA)
Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®) compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.
IDA is highly prevalent condition in subjects with cancer and gastrointestinal diseases such
as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have
undergone bariatric procedure or surgery. IDA can have a substantial medical and quality of
life (QoL) burden. Treatment of subjects diagnosed with IDA includes controlling the bleeding
and replenishing lost iron.
This study was designed to evaluate the safety and efficacy of iron isomaltoside/ferric
derisomaltose compared with iron sucrose in subjects diagnosed with IDA. In a subfraction of
35 subjects treated with iron isomaltoside/ferric derisomaltose, ECG and iron will be
frequently measured.
The study subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric
derisomaltose (1000 mg at baseline) or iron sucrose (200 mg IV injections at baseline and
repeated according to standard practice or physician choice up to a maximum of five times
within the first two weeks starting at baseline; a cumulative dose of 1000 mg was
recommended). The study subjects were monitored for up to 8 weeks from baseline.
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