期刊
NEPHROLOGY DIALYSIS TRANSPLANTATION
卷 26, 期 5, 页码 1599-1607出版社
OXFORD UNIV PRESS
DOI: 10.1093/ndt/gfq613
关键词
anaemia; CKD; ferritin; intravenous iron; transferrin saturation
资金
- American Regent, Shirley, NY, USA
- American Regent
- Amgen
- Janssen Cilag
- Roche
- Sandoz
- Vifor Pharma
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(2), 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.
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