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

摘要

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. 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. 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. 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. ClinicalTrials.gov NCT02546154 , 10 September 2015.