Table 3.

Other subsidiary efficacy outcomes

OutcomesEtelcalcetide GroupMaxacalcitol GroupP Value
Change in T50 from 0 to 3 mo, min16 (6 to 26)−11 (–21 to –0)<0.001
Change in T50 from 0 to 6 mo, min18 (6 to 31)−16 (–28 to –3)<0.001
Corrected Ca in target range, mo, n/N (%)
 375/149 (50)92/148 (62)0.06
 691/148 (62)90/141 (64)0.94
 1295/142 (67)83/132 (63)0.49
P in target range, mo, n/N (%)
 3110/149 (74)104/148 (70)0.66
 6117/148 (79)90/141 (64)0.002
 12101/142 (71)81/132 (61)0.08
Intact PTH in target range, mo, n/N (%)
 353/149 (36)80/148 (54)<0.001
 671/148 (48)76/141 (54)0.17
 1274/142 (52)74/132 (56)0.39
Ca, P, and intact PTH all in target range, mo, n/N (%)
 318/149 (12)41/148 (28)<0.001
 638/148 (26)30/141 (21)0.36
 1237/142 (26)33/132 (25)0.87
>30% reduction in intact PTH, mo, n/N (%)
 373/149 (49)121/148 (82)<0.001
 6101/148 (68)109/141 (77)0.04
 12102/142 (72)107/132 (81)0.04
Ca × P product, mo, mg2/dl2
 343 (40 to 45)54 (51 to 56)<0.001
 641 (39 to 44)54 (51 to 56)<0.001
 1245 (42 to 47)54 (51 to 56)<0.001
Fetuin-A, mo, µg/ml
 3243 (230 to 256)260 (247 to 273)0.01
 6246 (233 to 258)241 (229 to 254)0.50
 12259 (247 to 270)261 (250 to 273)0.63
Intact FGF23, mo, pg/ml
 3850 (661–11,093)3312 (2578–4256)<0.001
 6721 (556–934)4729 (3652–6125)<0.001
 12836 (629–1109)4853 (3660–6434)<0.001
  • Changes in T50 and other laboratory data excluding intact FGF23 are shown as least square means (95% confidence intervals). For intact FGF23, these values were calculated after logarithmic transformation, and the table gives the values by exponential retransformation. Laboratory data in target ranges are given in number of patients in target range (n), number of patients at each visit (N), and percentage in parentheses. Statistical analysis was done by adjusting for age, sex, and P level at baseline. The target ranges recommended by the clinical practice guideline by the Japanese Society for Dialysis Therapy (2012) were corrected C between 8.4 and 10.0 mg/dl, P between 3.5 and 6.0 mg/dl, and intact PTH between 60 and 240 pg/ml (24). The changes in T50 from 0 to 3 months and from 0 to 6 months were calculated with missing values being imputed by the last observation carried forward method. The numbers of patients in the target ranges are shown by the numbers of patients at each visit without imputation. All tests for between-group comparison were adjusted for age and serum P at baseline. T50, serum calcification propensity; Ca, calcium; 3, visit at 3 months; 6, visit at 6 months; 12, visit at 12 months; P, phosphate; PTH, parathyroid hormone; FGF23, fibroblast growth factor-23.