Please use this identifier to cite or link to this item: https://hdl.handle.net/1/158
Title: A Randomized Controlled Trial Comparing Intravenous Ferric Carboxymaltose with Oral Iron for Treatment of Iron Deficiency Anaemia of Non-Dialysis- Dependent Chronic Kidney Disease Patients
Authors: Qunibi, Wajeh Y ;Martinez, Carlos ;Smith, M.;Benjamin, Joseph ;Mangione, Antoinette ;Roger, Simon D 
Issue Date: May-2011
Source: Volume 26, Issue 5, pp. 1599-1607
Journal title: Nephrology Dialysis Transplantation
Abstract: Background. Iron deficiency is a common cause of anaemia and hyporesponsiveness to erythropoiesis-stimulating agents (ESAs) in non-dialysis-dependent chronic kidney disease (ND-CKD) patients. Current intravenous iron agents cannot be administered in a single high dose because of adverse effects. Ferric carboxymaltose, a non-dextran parenteral iron preparation, can be rapidly administered in high doses.Methods. This open-label trial randomized 255 subjects with glomerular filtration rates <= 45 mL/min/1.73 m<sup>2</sup>, haemoglobin <= 11 g/dL, transferrin saturation <= 25%, ferritin <= 300 ng/mL, and stable ESA dose to either intravenous ferric carboxymaltose 1000 mg over 15 min (with up to two additional doses of 500 mg at 2-week intervals) or oral ferrous sulphate 325 mg thrice daily for a total of 195 mg elemental iron daily for 56 days.Results. In the modified intent-to-treat population, the proportion of subjects achieving a haemoglobin increase < 1 g/dL at any time was 60.4% with ferric carboxymaltose and 34.7% with oral iron (P < 0.001). At Day 42, mean increase in haemoglobin was 0.95 +/- 1.12 vs 0.50 +/- 1.23 g/dL (P = 0.005), mean increase in ferritin was 432 +/- 189 ng/mL vs 18 +/- 45 ng/mL (P < 0.001) and mean increase in transferrin saturation was 13.6 +/- 11.9% vs 6.1 +/- 8.1% (P < 0.001). Treatment-related adverse events were significantly fewer with ferric carboxymaltose than with oral iron (2.7% and 26.2%, respectively; P < 0.0001).Conclusions. We conclude that 1000 mg ferric carboxymaltose can be rapidly administered, is more effective and is better tolerated than oral iron for treatment of iron deficiency in ND-CKD patients.
URI: https://elibrary.cclhd.health.nsw.gov.au/cclhdjspui/handle/1/158
DOI: 10.1093/ndt/gfq613
Pubmed: http://www.ncbi.nlm.nih.gov/pubmed/21034387
ISSN: 0931-0509
Publicaton type: Journal Article
Keywords: Drug Therapy
Kidney Disease
Haematology
Hematology
Anaemia
Anemia
Study or Trial: Randomized Controlled Clinical Trial/Controlled Clinical Trial
Appears in Collections:Renal Medicine

Show full item record

Page view(s)

4
checked on Jan 29, 2023

Google ScholarTM

Check

Altmetric


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.