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

Previous trials suggest that intravenous (IV) iron improves functional capacity, symptoms, and quality of life compared with placebo in heart failure patients. However, there exists limited evidence comparing the relative effects of different IV iron formulations in non-dialysis-dependent CKD patients. Sunil Bhandari and colleague conducted research under the title “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” published in Nephrology Dialysis Transplantation: international basic science and clinical renal journal (ndt). The summary of the findings is below:

Objectives:

To investigate the safety and efficacy of iron isomaltoside 1000/ferric derisomaltose (IIM) in patients with iron deficiency anemia and non-dialysis-dependent chronic kidney disease.

Method:

This randomized, open-label, and multi-center trial is conducted in the USA. In a 2-week period, patients were randomized in a 2:1 ratio for the administration of a single dose of 1000 mg IIM or iron sucrose (IS) administered as 200 mg IV injections up to five times. The primary outcomes included change in hemoglobin (Hb) from baseline to Week 8 and serious or severe hypersensitivity reactions. Secondary outcomes included the incidence of composite cardiovascular adverse events (AEs).

Findings:

Although no ideal IV is yet available in the US, investigators report that the ideal IV iron product would allow iron correction and improvement in hemoglobin (Hb) in a single visit with a short infusion time and would have minimal side effects. The study confirmed a serious hypersensitivity reaction with a low incidence and with no significant difference between both study groups. The IIM administration resulted in a significantly lower incidence of cardiovascular AEs, enhanced skeletal muscle energetics, and improved symptoms in patients with chronic heart failure as compared to the IS group. Hence, this study provides evidence for the use of IIM when IV iron is suggested for patients with an elevated risk of cardiovascular disease. There was a lower incidence of hypophosphatemia and improvement in fatigue symptoms in both the groups.

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