A prospective observational study of effectiveness and safety of iron isomaltoside in patients with chronic renal failure and iron deficiency anemia .

AIMS: The aim of this study was to investigate the effectiveness, safety, and tolerability of iron isomaltoside in routine practical care of iron deficiency anemia (IDA) in patients with chronic renal failure.

METHODS: The study included 698 patients with IDA on dialysis or with nondialysis chronic kidney disease (CKD) stages 3 - 5 designated by their physicians for treatment with iron isomaltoside. Data were recorded at baseline and after 3 and 9 months. Effectiveness data included measurement of hemoglobin (Hb), hematocrit, i-iron, transferrin saturation (TSAT), and i-ferritin. Safety data included adverse events and safety laboratory variables.

RESULTS: Following administration of a mean cumulative dose of 2,574 mg isomaltoside over 9 months, initial average Hb increased from 11.0 g/dL to 11.6 g/dL, TSAT from 19.4% to 28.3%, and i-ferritin from 320 µg/L to 642 µg/L, demonstrating a positive effect of iron isomaltoside on iron deficiency. In addition, there was a significant reduction in the use of erythropoiesis-stimulating agents (ESAs) (regarding epoetin α, initial mean dose 40,688 IU/month, final dose 35,665 IU/month, -13.7%, p < 0.001). No drug-related adverse events were reported. Furthermore, safety parameters including i-phosphate indicated no abnormal changes.

CONCLUSIONS: Iron isomaltoside demonstrated very good effectiveness and tolerability in patients with stage 3 - 5 CKD, including an ESA saving effect.
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