Table 2.

Efficacy parameter values (full analysis set analysis population)

ParameterJTT-751 (n=57)Placebo (n=29)Intergroup Differenceb; P Value
BLEOTChange from BLa; P ValueBLEOTChange from BLa; P Value
P (mg/dl)5.66±0.754.37±1.27−1.29 (−1.63 to −0.96); <0.001c5.57±0.635.62±0.890.06 (−0.20 to 0.31); 0.66c−1.31 (−1.80 to −0.82); <0.001d
Ca (mg/dl)8.61±0.528.82±0.570.21 (0.07 to 0.34); 0.004c8.57±0.448.57±0.43−0.01 (−0.14 to 0.13); 0.92c0.23 (0.03 to 0.42); 0.02d
Ca×P (mg2/dl2)48.75±6.9038.27±10.30−10.47 (−13.26 to −7.68); <0.001c47.68±5.2848.02±6.830.34 (−1.59 to 2.28); 0.72c−10.33 (−14.27 to −6.40); <0.001d
uPe (mg/d)380.6 (289.8, 519.6)211.2 (129.6, 307.1)−192.8 (−284, −136.8); <0.001f384 (272.8, 516)355.1 (263.5, 450)−71 (−114.4, 19.1); 0.03f<0.001g
iPTH (pg/ml)246 (129, 364)193 (117, 302)−25 (−111, 21); 0.001f236 (156, 331)214 (128, 339)7 (−30, 48); 0.67f0.03g
FGF-23 (pg/ml)453 (215, 800)209 (124, 510)−142 (−365, −40); <0.001f358 (237, 656)478 (239, 1100)67 (−17, 541); 0.002f<0.001g
  • Data are expressed as mean±SD or median (25th, 75th percentile interval). BL, baseline (the day of the start of treatment except for uP [week −2 to the day of the start of treatment]); EOT, end of treatment (week 12 or the observation day at the time of discontinuation); P, phosphate; Ca, calcium; uP, urinary phosphate; iPTH, intact PTH.

  • a Values of change from BL are expressed as mean (95% confidence interval), except for uP, iPTH, and FGF-23, which are expressed as median (25th, 75th percentile).

  • b Values of intergroup difference in P, Ca, and Ca×P are expressed as least squares mean difference (95% confidence interval).

  • c Paired t test.

  • d Analysis of covariance model.

  • e Full analysis set population is 53 patients in the JTT-751 group and 26 patients in the placebo group. Urine samples were obtained from 1-day urine collection.

  • f Wilcoxon signed rank test.

  • g Wilcoxon rank-sum test.