Table 3.

Baseline and changes in EPO, measures of iron metabolism and utilization 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)
EPO (U/L)
 Baseline, median12.4 (n=18)13.8 (n=13)9.9 (n=16)11.2 (n=18)9.6 (n=19)11.1 (n=18)8.9 (n=18)8.1 (n=19)
  Min, max6.4, 35.62.8, 21.83.1, 37.23.9, 28.42.5, 54.12.5, 37.72.5, 26.32.5, 39.9
 Peak, median16.6 (n=18)15.6 (n=13)22.4 (n=17)34.4 (n=18)424.9 (n=19)13.9 (n=19)12.7 (n=18)24.7 (n=17)
  Min, max9.7, 78.65.9, 26.710.5, 63.55.3, 69.09.8, 1371.23.5, 86.35.0, 57.16.6, 1786.5
 CFB at peak, median3.7 (n=18)2.6 (n=13)7.5 (n=16)18.3 (n=18)418.8 (n=19)2.1 (n=18)2.3 (n=18)14.1 (n=16)
  Min, max−2.7, 69.7−4.3, 10.9−9.3, 41.1−1.1, 60.2−17.8, 1339.4−19.9, 48.5−11.6, 42.5−7.1, 1775.6
Hepcidin (μg/L)
 Baseline, median295.4 (n=19)264.2 (n=16)308.0 (n=17)210.7 (n=18)286.3 (n=20)412.7 (n=21)351.5 (n=20)483.1 (n=19)
  Min, max116.0, 1022.440.6, 623.188.7, 520.0120.3, 994.961.5, 893.7119.8, 1567.051.9, 1238.393.5, 1241.8
 CFB at 4 wk, median−7.3 (n=15)−16.2 (n=10)−82.1 (n=15)−143.6 (n=16)−41.0 (n=18)154.0 (n=18)103.7 (n=17)−0.5 (n=17)
  Min, max−137.3, 286.3−222.1, 238.8−281.6, 158.8−441.7, 43.8−299.5, 266.6−141.9, 866.6−656.0, 463.4−379.4, 706.7
Ferritin (μg/L)
 Baseline243.7±161.1 (n=19)265.5±235.7 (n=16)350.5±266.4 (n=18)298.6±264.8 (n=18)441.7±252.4 (n=20)741.6±455.7 (n=21)686.6±483.8 (n=20)734.9±386.8 (n=19)
 CFB at 4 wk−24.3±38.6 (n=15)−35.8±54.7 (n=12)−8.2±268.8 (n=17)−101.8±91.1 (n=17)−27.9±166.0 (n=19)74.2±174.0 (n=19)−5.8±178.7 (n=18)−80.8±95.9 (n=17)
Transferrin saturation (%)
 Baseline22.1±7.5 (n=19)21.6±7.4 (n=16)25.5±6.4 (n=18)25.6±7.5 (n=18)28.4±12.3 (n=20)30.0±11.0 (n=21)33.0±14.4 (n=20)32.6±12.0 (n=19)
 CFB at 4 wk1.5±6.1 (n=15)−3.1±4.9 (n=12)−2.6±6.2 (n=17)−3.4±11.3 (n=17)1.2±13.0 (n=19)7.7±20.1 (n=18)10.1±15.4 (n=18)0.3±11.8 (n=17)
Transferrin (g/L)
 Baseline2.0±0.3 (n=19)2.2±0.3 (n=16)2.1±0.4 (n=18)2.3±0.5 (n=18)1.9±0.4 (n=20)1.7±0.4 (n=21)1.6±0.3 (n=20)1.7±0.5 (n=19)
 CFB at 4 wk0.01±0.3 (n=15) 0.03±0.3 (n=12)0.29±0.3 (n=17)0.39±0.4 (n=17)0.0±0.3 (n=19)0.1±0.5 (n=19)0.2±0.2 (n=18)0.2±0.3 (n=17)
Total iron binding capacity (μmol/L)
 Baseline49.1±4.3 (n=19)53.4±7.7 (n=16)51.8±9.5 (n=18)56.0±10.3 (n=18)44.6±8.5 (n=20)41.4±8.8 (n=21)39.3±5.5 (n=20)41.1±8.9 (n=19)
 CFB at 4 wk−0.5±3.7 (n=15)0.3±6.3 (n=12)5.1±4.1 (n=17)8.3±5.5 (n=17)1.0±4.6 (n=19)3.3±6.3 (n=18)3.9±3.4 (n=18)5.2±3.2 (n=17)
Total serum iron (μmol/L)
 Baseline10.8±3.7 (n=19)11.2±3.3 (n=16)12.9±3.1 (n=18)14.1±4.0 (n=18)12.5±5.5 (n=20)12.1±4.4 (n=21)12.9±5.6 (n=20)12.8±3.4 (n=19)
 CFB at 4 wk0.6±2.8 (n=15)−1.7±3.3 (n=12) −0.4±3.3 (n=17)−0.4±6.1 (n=17)0.4±5.7 (n=19)5.0±9.5 (n=19)5.7±6.9 (n=18)2.2±4.7 (n=17)
VEGF (ng/L)
 Baseline90.4±123.3 (n=19)76.1±55.7 (n=16)82.5±89.2 (n=17)63.6±32.4 (n=18)87.5±46.7 (n=19)124.7±55.4 (n=21)113.7±67.3 (n=20)116.7±82.6 (n=19)
 CFB at 4 wk−43.3±136.0 (n=15)0.8±37.9 (n=9)−3.9±36.5 (n=15)5.6±41.4 (n=15)1.2±40.3 (n=16)−21.4±50.1 (n=17)−4.6±60.8 (n=17)19.9±79.6 (n=17)
  • Analysis based on the intent-to-treat population. Unless otherwise indicated, all values are mean±SD. CFB, change from baseline.