title: A randomized trial of iron isomaltoside 1000 versus oral iron in non-dialysis-dependent chronic kidney disease patients with anaemia.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
authors.affiliation: Salford Royal NHS Foundation Trust, Salford, UK.
authors.forename: Philip A
authors.initials: PA
authors.lastname: Kalra
authors.affiliation: Hull and East Yorkshire Hospitals NHS Trust, Hull and Hull York Medical School, Kingston Upon Hull, UK.
authors.forename: Sunil
authors.initials: S
authors.lastname: Bhandari
authors.affiliation: Pushpawati Singhaniya Research Institute, New Delhi, India.
authors.forename: Sanjiv
authors.initials: S
authors.lastname: Saxena
authors.affiliation: SMS Medical College Hospital, Jaipur, Rajasthan, India.
authors.forename: Dhananjai
authors.initials: D
authors.lastname: Agarwal
authors.affiliation: Dialysis Centre Kamen, Kamen, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Wirtz
authors.affiliation: 3 Department of Medicine, Socio-Medical Centre East-Danube Hospital, Vienna, Austria.
authors.forename: Josef
authors.initials: J
authors.lastname: Kletzmayr
authors.affiliation: Pharmacosmos A/S, Holbaek, Denmark.
authors.forename: Lars L
authors.initials: LL
authors.lastname: Thomsen
authors.affiliation: Washington University School of Medicine, St. Louis, MO, USA.
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Coyne
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000209:etiology; D004187:Disaccharides / Q000627:therapeutic use*; D005260:Female; D005290:Ferric Compounds / Q000627:therapeutic use*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007501:Iron / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004187:Disaccharides; D005290:Ferric Compounds; D006454:Hemoglobins; C557707:iron isomaltoside 1000; D007501:Iron
keywords: chronic kidney disease; iron isomaltoside 1000; iron treatment