Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease

Summary

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).

Timeline

Start

2016-11-29

Primary completion

2018-05-29

Completion

2018-05-29

Outcome

Met primary endpoint

paper The co-primary safety objective was met PMID 32049331 ↗

paper change in Hb to Week 8 showed non-inferiority, confirming that the co-primary efficacy objective was met. PMID 32049331 ↗

Publications

• Results Sunil Bhandari, Lars Lykke Thomsen. Single 1000 mg infusion of iron isomaltoside1000 single 1000 mg infusion of iron isomaltoside 1000 demonstrates a more rapid hemoglobin response and reduced risk of cardiovascular adverse events compared to multiple dose iron sucrose In patients with iron deficiency anemia and nondialysis-dependent CKD. Nephrology Dialysis Transplantation 34 (Supplement 1): i349-i350, 2019, https://academic.oup.com/ndt/article/34/Supplement_1/gfz101.SaO035/5515662
• Bhandari S, Kalra PA, Berkowitz M, Belo D, Thomsen LL, Wolf M. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial. Nephrol Dial Transplant. 2021 Jan 1;36(1):111-120. doi: 10.1093/ndt/gfaa011.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ferric derisomaltose	Unknown	1000 mg	Intravenous
Comparator	Iron sucrose	Unknown	200 mg	Intravenous

Indications