A randomized, open-label trial of iron isomaltoside 1000 (Monofer®) compared with iron sucrose (Venofer®) as maintenance therapy in haemodialysis patients.
BACKGROUND
Iron deficiency anaemia is common in patients with chronic kidney disease, and intravenous iron is the preferred treatment for those on haemodialysis. The aim of this trial was to compare the efficacy and safety of iron isomaltoside 1000 (Monofer®) with iron sucrose (Venofer®) in haemodialysis patients.


METHODS
This was an open-label, randomized, multicentre, non-inferiority trial conducted in 351 haemodialysis subjects randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sucrose (Group B). Subjects in Group A were equally divided into A1 (500 mg single bolus injection) and A2 (500 mg split dose). Group B were also treated with 500 mg split dose. The primary end point was the proportion of subjects with haemoglobin (Hb) in the target range 9.5-12.5 g/dL at 6 weeks. Secondary outcome measures included haematology parameters and safety parameters.


RESULTS
A total of 351 subjects were enrolled. Both treatments showed similar efficacy with >82% of subjects with Hb in the target range (non-inferiority, P = 0.01). Similar results were found when comparing subgroups A1 and A2 with Group B. No statistical significant change in Hb concentration was found between any of the groups. There was a significant increase in ferritin from baseline to Weeks 1, 2 and 4 in Group A compared with Group B (Weeks 1 and 2: P < 0.001; Week 4: P = 0.002). There was a significant higher increase in reticulocyte count in Group A compared with Group B at Week 1 (P < 0.001). The frequency, type and severity of adverse events were similar.


CONCLUSIONS
Iron isomaltoside 1000 and iron sucrose have comparative efficacy in maintaining Hb concentrations in haemodialysis subjects and both preparations were well tolerated with a similar short-term safety profile.
Hull and East Yorkshire Hospitals NHS Trust, Hull, UK.
Sunil
S
Bhandari
Salford Royal NHS Foundation Trust, Salford, UK.
Philip A
PA
Kalra
P. D. Hinduja National Hospital and Research Center Mumbai, Mumbai, India.
Jatin
J
Kothari
Leiter Abteilung Nephrologie, Stadtspital Waid Zürich, Zürich, Switzerland.
Patrice M
PM
Ambühl
Aalborg University Hospital, Aalborg, Denmark.
Jeppe H
JH
Christensen
City Clinical Hospital #31, Saint Petersburg, Russia.
Ashot M
AM
Essaian
Pharmacosmos A/S, Holbaek, Denmark.
Lars L
LL
Thomsen
King's College Hospital London, London, UK.
Iain C
IC
Macdougall
Washington University School of Medicine St. Louis, St. Louis, MO, USA.
Daniel W
DW
Coyne
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000209:etiology; D004187:Disaccharides / Q000627:therapeutic use*; D018479:Early Intervention, Educational; D005260:Female; D005290:Ferric Compounds / Q000627:therapeutic use*; D000077605:Ferric Oxide, Saccharated; D005293:Ferritins / Q000378:metabolism; D005937:Glucaric Acid / Q000627:therapeutic use*; D006397:Hematinics / Q000627:therapeutic use*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000628:therapy; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D004187:Disaccharides; D005290:Ferric Compounds; D006397:Hematinics; D006454:Hemoglobins; C557707:iron isomaltoside 1000; D005293:Ferritins; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid
chronic kidney disease; iron isomaltoside 1000; iron treatment