Chronic Kidney Disease 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 Anaemia and Non-dialysis-dependent Chronic Kidney Disease (FERWON-NEPHRO)
Evaluation of safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose, in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).
Iron deficiency anaemia (IDA) is a common problem associated with many chronic diseases such
as chronic kidney disease (CKD). IDA can have a substantial medical and quality of life (QoL)
burden on the subjects. Therapy of these subjects includes treating the underlying cause of
IDA and restoring haemoglobin (Hb) concentration and iron stores.
This study evaluated the safety and efficacy of iron isomaltoside/ferric derisomaltose
compared with iron sucrose in subjects with both non-dialysis-dependent chronic kidney
disease (NDD-CKD) and iron deficiency anaemia (IDA).
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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