Table 3.

Calcium and phosphorus levels during efficacy assessment phase

Control(n = 101)Cinacalcet(n = 294)Cinacalcet Randomization Strata
Hemodialysis/Baseline iPTH Strata (pg/ml)Peritoneal Dialysis(n = 34)
300–500(n = 74)501–800(n = 84)>800(n = 102)All(n = 260)
Serum calcium (mg/dl)a
    n100288708310125434
    mean (SE)10.1 (0.1)9.1 (0.1)c9.1 (0.1)9.1 (0.1)9.1 (0.1)9.1 (0.1)9.4 (0.1)
Percent change in calciuma,b
    n100288708310125434
    mean (SE)0.9 (0.5)−6.5 (0.6)c−5.5 (1.0)−5.8 (1.1)−7.4 (1.0)−6.3 (0.6)−7.4 (1.4)
Serum phosphorus (mg/dl)a
    n100289718310125534
    mean (SE)5.8 (0.1)5.5 (0.1)5.1 (0.2)5.3 (0.2)6.0 (0.2)5.5 (0.1)5.0 (0.2)
Percent change in phosphorusa,b
    n100289718310125534
    mean (SE)−2.2 (2.5)−7.2 (1.6)d−8.6 (2.7)−2.9 (3.6)−11.7 (2.3)−8.0 (1.7)−1.5 (4.0)
Ca × P (mg2/dl2)a
    n100288708310125434
    mean (SE)58.1 (1.3)50.0 (0.9)c46.9 (1.8)48.5 (1.7)54.1 (1.5)50.3 (1.0)47.4 (2.2)
Percent change in Ca × Pa,b
    n100287698310125334
    mean (SE)−1.4 (2.4)−12.8 (1.7)c−12.0 (3.4)−9.1 (3.5)−18.0 (2.5)−13.4 (1.8)−8.5 (4.1)
No. (%) achieving Ca × P target
    mean Ca × P <55 mg2/dl2a45/100 (45%)186/288 (65%)c51/70 (73%)58/83 (70%)51/101 (50%)160/254 (63%)26/34 (76%)
    Ca × P reduction ≤5 mg2/dl2a,b39/100 (39%)175/287 (61%)c41/69 (59%)48/83 (58%)67/101 (66%)156/253 (62%)19/34 (56%)
    Ca × P reduction ≤10 mg2/dl2a,b24/100 (24%)135/287 (47%)c29/69 (42%)32/83 (39%)59/101 (58%)120/253 (47%)15/34 (44%)
  • a Mean value in efficacy assessment phase was based on an average of biweekly measurements during weeks 18 to 26 of study treatment (up to five values for each patient). For patients with no values during weeks 18 to 26, the mean of the last two on-study post-baseline values was used as the week 18 to 26 average.

  • b Percentage change/reduction from baseline in each patient was calculated from mean values in the efficacy assessment phase and the average of two values during the 30-day baseline period before study treatment.

  • c P < 0.001 versus control group.

  • d P < 0.05 versus control group.