NIMO-CKD-UK: a real-world, observational study of iron isomaltoside in patients with iron deficiency anaemia and chronic kidney disease

Abstract

Background: Intravenous iron is often used to treat iron deficiency anaemia in non-dialysis chronic kidney disease (ND-CKD), but the optimal dosing regimen remains unclear. We evaluated the impact of high- versus low-dose intravenous iron isomaltoside on the probability of retreatment with intravenous iron in iron-deficient ND-CKD patients.

Methods: This real-world, prospective, observational study collected data from 256 ND-CKD patients treated for anaemia in the UK. Following an initial course of iron isomaltoside, patients were followed for ≥12 months. Iron dose and the need for retreatment were determined at the investigators' discretion. The primary study outcome was the need for retreatment at 52 weeks compared between patients who received >1000 mg of iron during Course 1 and those who received ≤1000 mg. Safety was evaluated through adverse drug reactions.

Results: The probability of retreatment at Week 52 was significantly lower in the >1000 mg iron group (n = 58) versus the ≤1000 mg group (n = 198); hazard ratio (95% confidence interval [CI]): 0.46 (0.20, 0.91); p = 0.012. Mean (95% CI) haemoglobin increased by 6.58 (4.94, 8.21) g/L in the ≤1000 mg group and by 10.59 (7.52, 13.66) g/L in the >1000 mg group (p = 0.024). Changes in other blood and iron parameters were not significantly different between the two groups. Administering >1000 mg of iron isomaltoside saved 8.6 appointments per 100 patients compared to ≤1000 mg. No serious adverse drug reactions were reported. Of the patients who received ≤1000 mg of iron in this study, 82.3% were eligible for a dose >1000 mg.

Conclusions: The >1000 mg iron isomaltoside regimen reduced the probability of retreatment, achieved a greater haemoglobin response irrespective of erythropoiesis-stimulating agent treatment, and reduced the total number of appointments required, compared to the ≤1000 mg regimen. Many of the patients who received ≤1000 mg of iron were eligible for >1000 mg, indicating that there was considerable underdosing in this study.

Trial registration: ClinicalTrials.gov NCT02546154 , 10 September 2015.

Keywords: Anaemia; Chronic kidney disease; Ferric derisomaltose; Intravenous iron; Iron deficiency; Iron isomaltoside 1000; Non-dialysis dependent; Observational; Real-world.

Fig. 1

Patient disposition. ^aProtocol deviation. IV intravenous

Fig. 2

Probability of no retreatment with IV iron, by IIM dose administered during Course 1. IIM iron isomaltoside, IV intravenous, n number of patients included in the analysis

Fig. 3

Proportion of patients with Hb ≥110 g/L before and after IIM – patients receiving ESA at baseline. Statistical analyses comparing higher and lower dose groups were performed for baseline and Course 1 only. ESA erythropoiesis-stimulating agent, Hb haemoglobin, n number of patients with data

Fig. 4

Proportion of patients with Hb ≥110 g/L before and after IIM – patients not receiving ESA at baseline. *p < 0.05 versus ≤1000 mg; statistical analyses comparing higher and lower dose groups were performed for baseline and Course 1 only. ESA erythropoiesis-stimulating agent, Hb haemoglobin, n number of patients with data