Table 3.

Special clinical laboratory evaluations (safety analysis population)

ParameterJTT-751PlaceboIntergroup Difference P Value
nBLEOTP ValuenBLEOTP Value
Serum iron (μg/dl)6071.5±27.2105.2±46.7<0.001a3064.2±32.470.0±32.60.42a0.001b
Ferritin (ng/ml)6069.00±50.92204.01±106.54<0.001a30105.98±95.5893.66±82.700.45a<0.001b
TIBC (μg/dl)60269.2±42.8242.0±34.9<0.001a30263.4±48.0264.0±37.50.61a<0.001b
TSAT (%)6027.22±11.3044.19±20.88<0.001a3024.99±12.7527.03±12.600.70a<0.001b
Hemoglobin (g/dl)6010.25±1.4610.71±1.880.04c3010.52±1.2710.58±1.260.74c0.23d
1,25-(OH)2 VDe (pg/ml)5717.66±8.9618.12±6.990.65c2917.45±7.8319.18±10.010.19c0.46d
25-OH VDe (ng/ml)5721.3±7.621.9±7.70.38c2920.9±8.020.6±8.50.78c0.46d
Cystatin C (mg/L)604.526±0.7784.692±1.0070.03c304.369±0.6684.516±0.7480.09c0.88d
eGFR (ml/min per 1.73 m2)608.61±3.937.86±4.320.001c309.79±8.238.98±7.340.03c0.88d
uCa (mg/d)5527.33±17.7326.64±16.570.72c2719.89±12.0924.04±16.400.22c0.17d
ePIe (g/d)4941.80±15.3738.17±11.140.01c2640.38±12.4637.54±12.590.23c0.75d
  • Data are expressed as mean±SD. BL, baseline; TIBC, total iron-binding capacity; TSAT, transferring saturation; 1,25-(OH)2 VD, 1,25-dihydroxy vitamin D; 25-OH VD, 25-hydroxy vitamin D; uCa, urinary calcium; ePI, estimated protein intake.

  • a Wilcoxon signed rank test.

  • b Wilcoxon rank-sum test.

  • c Paired t test

  • d t test.

  • e Data are expressed as full analysis set population.