NDT Advance Access published online on November 10, 2009
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfp584
Maintenance of elevated versus physiological iron indices in non-anaemic patients with chronic kidney disease: a randomized controlled trial
1 Department of Renal Medicine, Eastern Health, Melbourne, Victoria, Australia 2 Nephrology Department, Monash Medical Centre, Melbourne, Victoria, Australia 3 Nephrology Department, Royal Brisbane Hospital, Brisbane, Queensland, Australia 4 Nephrology Department, Royal Perth Hospital, Perth, Western Australia, Australia 5 Nephrology Department, Royal North Shore Hospital, Sydney, New South Wales, Australia 6 Renal Research Unit, Gosford Hospital, Gosford, New South Wales, Australia
Correspondence and offprint requests to: Lawrence McMahon; E-mail: lawrence.mcmahon{at}easternhealth.org.au; lawrence.mcmahon{at}mh.org.au
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Abstract |
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Background. An optimal haemoglobin (Hb) response to erythropoietin requires elevated iron indices in dialysis patients; however, it is unknown if the same applies in chronic kidney disease (CKD).
Methods. One hundred patients [CKD Stages 3–5, Hb 
110 g/L, iron replete, erythropoietin-stimulating agent (ESA)-naive, 47% diabetic, median age 69.5 years] were block-randomized in an open-label study to receive up to 200 mg intravenous iron sucrose (Group A, n = 52) bimonthly or oral iron sulphate (Group B) to maintain raised and normal iron indices (respectively) over 12 months. The primary endpoint was the change in Hb concentration at 12 months or at termination after at least 6 months of treatment.
Results. Eighty-five patients reached the primary endpoint (43, Group A; 42, Group B). Initial Hb was 119 ± 7 vs 116 ± 12 g/L (mean ± standard deviation); ferritin 122 (71–176), median (inter-quartile range), vs 90 µg/L (58–150); transferrin saturation (TSat) 22 (18–26) vs 21% (15–24); and creatinine 240 (195–313) vs 230 µmol/L (184–352). Ferritin and TSat differed by month 2 [157 (103–220) vs 96 µg/L (73–162), P = 0.003] and month 6 [25 (20–31) vs 21% (17–27), P = 0.02], respectively. At study end, Hb did not differ between groups (121 ± 10 vs 117 ± 13 g/L). Ferritin was 362 (310–458) vs 125 µg/L (84–190), P < 0.001; TSat 30 (23–34) vs 21% (18–24), P < 0.001; and creatinine 229 (188–326) vs 272 µmol/L (195–413), P = NS. For patients (Groups A and B, n = 27 in each group) whose creatinine regression slope increased (indicating worsening function), the fall in Hb over 12 months also did not differ between groups despite adequate separation in iron indices. Serious adverse events overall did not differ between groups.
Conclusions. Elevated iron indices did not increase Hb synthesis in ESA-naive, iron replete, pre-dialysis patients with Hb >110 g/L.
Keywords: chronic kidney disease; haemoglobin; iron sucrose; oral iron; randomized controlled trial
Received for publication: 25. 9.09
Accepted in revised form: 12.10.09