Parameter | JTT-751 (n=57) | Placebo (n=29) | Intergroup Difference^{b}; P Value | ||||
---|---|---|---|---|---|---|---|

BL | EOT | Change from BL^{a}; P Value | BL | EOT | Change from BL^{a}; P Value | ||

P (mg/dl) | 5.66±0.75 | 4.37±1.27 | −1.29 (−1.63 to −0.96); <0.001^{c} | 5.57±0.63 | 5.62±0.89 | 0.06 (−0.20 to 0.31); 0.66^{c} | −1.31 (−1.80 to −0.82); <0.001^{d} |

Ca (mg/dl) | 8.61±0.52 | 8.82±0.57 | 0.21 (0.07 to 0.34); 0.004^{c} | 8.57±0.44 | 8.57±0.43 | −0.01 (−0.14 to 0.13); 0.92^{c} | 0.23 (0.03 to 0.42); 0.02^{d} |

Ca×P (mg^{2}/dl^{2}) | 48.75±6.90 | 38.27±10.30 | −10.47 (−13.26 to −7.68); <0.001^{c} | 47.68±5.28 | 48.02±6.83 | 0.34 (−1.59 to 2.28); 0.72^{c} | −10.33 (−14.27 to −6.40); <0.001^{d} |

uP^{e} (mg/d) | 380.6 (289.8, 519.6) | 211.2 (129.6, 307.1) | −192.8 (−284, −136.8); <0.001^{f} | 384 (272.8, 516) | 355.1 (263.5, 450) | −71 (−114.4, 19.1); 0.03^{f} | <0.001^{g} |

iPTH (pg/ml) | 246 (129, 364) | 193 (117, 302) | −25 (−111, 21); 0.001^{f} | 236 (156, 331) | 214 (128, 339) | 7 (−30, 48); 0.67^{f} | 0.03^{g} |

FGF-23 (pg/ml) | 453 (215, 800) | 209 (124, 510) | −142 (−365, −40); <0.001^{f} | 358 (237, 656) | 478 (239, 1100) | 67 (−17, 541); 0.002^{f} | <0.001^{g} |

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.