Table 2.

Baseline and mean changes in modeled and observed hemoglobin (in grams per decaliter) after 4 weeks of treatment with GSK1278863

ParameterNondialysis StudyHDD Study
Placebo (n=19)GSK1278863rhEPO (n=20)GSK1278863
0.5 mg (n=16)2 mg
(n=18)5 mg (n=18)0.5 mg (n=21)2 mg
(n=20)5 mg
(n=19)
Baseline 9.91±0.57 (n=19)9.98±0.58 (n=16)9.74±0.70 (n=18)10.08±0.72 (n=18)10.89±0.52 (n=20)10.66±0.66 (n=21)10.75±0.60 (n=20)10.80±0.61 (n=19)
 Modeled CFB at 4 wka−0.15±0.19 (n=18)0.13±0.22 (n=13)0.46±0.22 (n=17)1.01±0.26 (n=18)−0.27±0.63 (n=19)−1.13±0.68 (n=20) −1.07±0.77 (n=20)0.21±0.75 (n=18)
 Observed CFB at 4 wk−0.23±0.51 (n=15)−0.12±0.51 (n=11)0.12±0.51 (n=15)d0.95±0.66 (n=17)−0.25±0.81 (n=19)−1.06±0.83 (n=18)−0.93±0.82 (n=18)−0.08±0.63 (n=17)
Maximum change in hemoglobin over 4 wkb0.15±0.10 (n=19)0.13±0.13 (n=16)0.49±0.21 (n=18)1.05±0.15 (n=18)
 Model adjusted0.15±0.15 (n=19)0.14±0.16 (n=16)0.47±0.15 (n=18)1.07±0.15 (n=18)
 95% CI−0.14 to 0.45−0.18 to 0.460.17 to 0.780.76 to 1.37
Summary of hemoglobin variabilityc(n=19)(n=20)(n=20)(n=18)
 Within-subject SD0.35±0.190.53±0.270.55±0.330.40±0.36
  Min, max0.1, 0.80.1, 10.1, 1.10.1, 1.7
 Residual SD0.20±0.110.24±0.110.26±0.120.26±0.31
  Min, max0.1, 0.50.1, 0.60.1, 0.50.1, 1.4
 Hemoglobin AUC10.89±8.6916.67±9.6418.76±12.7511.89±8.06
  Min, max1.1, 324.3, 37.83.6, 45.32.9, 32.4
  • Analysis based on the intent-to-treat population. CFB, change from baseline; 95% CI, 95% confidence interval; min, minimum; max, maximum; AUC, area under the curve.

  • a For modeled change at week 4, patients required a baseline and ≥2 nonmissing postbaseline values. If the Quest hemoglobin value was missing and a HemoCue value present, the HemoCue value was used.

  • b Not applicable for the HDD study.

  • c Not applicable for the nondialysis study.

  • d Excluding a single outlier in the patients not undergoing dialysis (see the Supplemental Material for details).