Table 2.

Reduction of iPTH 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)
Mean iPTH level (pg/ml)a
    n100288708310125434
    mean (SE)852.0 (55.1)525.5 (30.1)c223.1 (17.4)362.1 (26.5)857.2 (55.2)520.6 (29.7)561.9 (126.8)
Percentage change in mean iPTHa,b n100288708310125434
    mean (SE)4.1 (3.4)−40.3 (2.1)c−46.7 (3.9)−44.0 (3.8)−33.3 (3.6)−40.5 (2.2)−38.8 (5.7)
No. (%) achieving target
    mean level ≤250 pg/mla7/100 (7%)111/288 (39%)c54/70 (77%)34/83 (41%)10/101 (10%)98/254 (39%)13/34 (38%)
    mean level ≤300 pg/mla9/100 (9%)132/288 (46%)c57/70 (81%)41/83 (49%)17/101 (17%)115/254 (45%)17/34 (50%)
    reduction ≥20%a,b21/100 (21%)213/288 (74%)c58/70 (83%)64/83 (77%)66/101 (65%)188/254 (74%)25/34 (74%)
    reduction ≥30%a,b13/100 (13%)187/288 (65%)c55/70 (79%)57/83 (69%)53/101 (52%)165/254 (65%)22/34 (65%)
    reduction ≥40%a,b10/100 (10%)172/288 (60%)c49/70 (70%)55/83 (66%)48/101 (48%)152/254 (60%)20/34 (59%)
    reduction ≥50%a,b6/100 (6%)139/288 (48%)c45/70 (64%)42/83 (51%)38/101 (38%)125/254 (49%)14/34 (41%)
  • 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 postbaseline values was used as the week 18 to 26 average.

  • b Percentage change/reduction from baseline in each subject 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.