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.

Conflict of interest statement

Pharmacosmos UK Ltd. sponsored the study. PAK and SB have received consultancy fees, speaker honoraria and educational grants from Pharmacosmos and Vifor Pharma. MS is an employee of Pharmacosmos UK Ltd. RD has received consultancy fees, speaker honoraria and educational grants from Pharmacosmos. DR has received consultancy fees and educational grants from Pharmacosmos. SL has received consultancy fees from Pharmacosmos. AM and KM have received consultancy fees from Pharmacosmos and Vifor Pharma. NP has received speaker honoraria from Pharmacosmos. JM has no conflicts of interest.

Figures

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