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

BMC Nephrol. 2020 Dec 10;21(1):539. doi: 10.1186/s12882-020-02180-2.

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.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intravenous
  • Anemia, Iron-Deficiency / blood
  • Anemia, Iron-Deficiency / complications
  • Anemia, Iron-Deficiency / drug therapy*
  • Anemia, Iron-Deficiency / physiopathology
  • Disaccharides / administration & dosage*
  • Disaccharides / therapeutic use
  • Fatigue / physiopathology
  • Female
  • Ferric Compounds / administration & dosage*
  • Ferric Compounds / therapeutic use
  • Hematinics / administration & dosage*
  • Hematinics / therapeutic use
  • Hemoglobins / metabolism
  • Humans
  • Male
  • Proportional Hazards Models
  • Prospective Studies
  • Renal Insufficiency, Chronic / blood*
  • Renal Insufficiency, Chronic / complications
  • Retreatment
  • Severity of Illness Index
  • Treatment Outcome
  • United Kingdom

Substances

  • Disaccharides
  • Ferric Compounds
  • Hematinics
  • Hemoglobins
  • iron isomaltoside 1000

Associated data

  • ClinicalTrials.gov/NCT02546154