Table 4.

Baseline and postdose measurements of hemoglobin and iron indices (intent-to-treat population)

ParameteraFerumoxytol (n=80)Iron Sucrose (n=82)P Valueb
Hemoglobin, g/dl (mean±SD)
 Baseline10.1±0.910.0±1.0
 Week 210.6±1.010.2±0.9
 Change from baseline to week 2c0.6±0.10.3±0.10.01
 Week 310.7±1.010.4±0.9
 Change from baseline to week 3c0.7±0.10.4±0.1<0.05
 Week 410.8±1.010.6±1.0
 Change from baseline to week 4c0.8±0.10.7±0.10.40
 Week 510.8±1.010.7±1.0
 Change from baseline to week 5c0.8±0.10.7±0.10.52
Hemoglobin≥1-g/dl increase from baseline (%)
 Week 225.013.4
 Week 340.024.4
 Week 446.337.8
 Week 5d50.041.50.29
Transferrin saturation, % (mean±SD)
 Baseline21.5±18.118.9±11.8
 Week 233.0±13.126.0±17.2
 Week 330.3±11.523.5±7.4
 Week 430.0±11.626.0±11.0
 Week 527.5±8.025.5±12.7
Ferritin, ng/ml (median [quartile 1, quartile 3])
 Baseline164 (72, 381)150 (51, 417)
 Week 2854 (593, 1143)509 (341, 752)
 Week 3788 (467, 1096)546 (363, 817)
 Week 4647 (348, 1016)509 (304, 747)
 Week 5631 (361, 881)456 (258, 671)
Serum iron, μg/dl (mean±SD)
 Baseline57.7±46.052.5±31.7
 Week 280.0±32.766.8±42.6
 Week 372.0±28.260.1±20.7
 Week 470.4±32.266.3±25.9
 Week 564.2±20.864.2±26.9
  • a Means associated with P values for change in hemoglobin from baseline are least square means adjusted for covariates (reported as least square means±SEMs). Other means are arithmetic means (reported as means±SDs).

  • b All P values refer to comparisons between treatment groups.

  • c For analysis of the change from baseline, P values were calculated using ANOVA adjusted for baseline hemoglobin level and hemodialysis status.

  • d P value for percent with ≥1-g/dl increase in hemoglobin is from the Cochran–Mantel–Haenszel test adjusted for baseline hemoglobin level and hemodialysis status.