TY - JOUR T1 - A randomized trial of iron isomaltoside 1000 versus oral iron in non-dialysis-dependent chronic kidney disease patients with anaemia. AU - Kalra,Philip A, AU - Bhandari,Sunil, AU - Saxena,Sanjiv, AU - Agarwal,Dhananjai, AU - Wirtz,Georg, AU - Kletzmayr,Josef, AU - Thomsen,Lars L, AU - Coyne,Daniel W, Y1 - 2015/08/06/ PY - 2015/03/19/received PY - 2015/07/09/accepted PY - 2015/8/8/entrez PY - 2015/8/8/pubmed PY - 2017/7/19/medline KW - chronic kidney disease KW - iron isomaltoside 1000 KW - iron treatment SP - 646 EP - 55 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol Dial Transplant VL - 31 IS - 4 N2 - BACKGROUND: Iron deficiency anaemia is common in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and is often treated with oral or intravenous (IV) iron therapy. This trial compared the efficacy and safety of IV iron isomaltoside 1000 (Monofer®) and oral iron in NDD-CKD patients with renal-related anaemia. METHODS: The trial was a Phase III open-label, comparative, multicentre, non-inferiority trial conducted in 351 iron-deficient NDD-CKD patients, randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sulphate administered as 100 mg elemental oral iron twice daily (200 mg daily) for 8 weeks (Group B). The patients in Group A were randomized into A1 (infusion of max. 1000 mg single doses over 15 min) and A2 (bolus injections of 500 mg over 2 min). A modified Ganzoni formula was used to calculate IV iron need. The primary end point was change in haemoglobin concentrations from baseline to Week 4. RESULTS: Iron isomaltoside 1000 was both non-inferior to oral iron at Week 4 (P < 0.001) and sustained a superior increase in haemoglobin from Week 3 until the end of the study at Week 8 (P = 0.009 at Week 3). The haemoglobin response was more pronounced with iron isomaltoside 1000 doses ≥1000 mg (P < 0.05). Serum-ferritin and transferrin saturation concentrations were also significantly increased with IV iron. Adverse drug reactions were observed in 10.5% in the iron isomaltoside 1000 group and 10.3% in the oral iron group. More patients treated with oral iron sulphate withdrew from the study due to adverse events (4.3 versus 0.9%, P = 0.2). CONCLUSIONS: Iron isomaltoside 1000 was more efficacious than oral iron for increase in haemoglobin and proved to be well tolerated at the tested dose levels in NDD-CKD patients. SN - 1460-2385 UR - https://www.unboundmedicine.com/medline/citation/26250435/A_randomized_trial_of_iron_isomaltoside_1000_versus_oral_iron_in_non_dialysis_dependent_chronic_kidney_disease_patients_with_anaemia_ L2 - https://academic.oup.com/ndt/article-lookup/doi/10.1093/ndt/gfv293 DB - PRIME DP - Unbound Medicine ER -