Table 2.

Lead-in study baseline demographics, key laboratory values, and medical history of subjects of the extension study

CharacteristicOriginal Cinacalcet (n = 334)Original Placebo (n = 255)
Sex, n (%)
    Male210 (63)166 (65)
    Female124 (37)89 (35)
Race, n (%)
    White159 (48)157 (62)
    Black123 (37)70 (27)
    Other52 (16)28 (11)
Age
    Mean (SD), years50.9 (14.1)53.3 (14.9)
    Median (Q1, Q3), years51.0 (40.0, 61.0)53.0 (41.0, 65.0)
    <65 yr, n (%)273 (82)189 (74)
    ≥65 yr, n (%)61 (18)66 (26)
Duration of dialysis a, months
    Mean (SD)69.6 (62.4)71.7 (69.2)
    Median (Q1, Q3)51.0 (23.0, 94.0)47.0 (23.0, 90.0)
PTH, pg/ml
    Mean (SD)773.50 (651.34)693.82 (392.20)
    Median (Q1, Q3)613.08 (435.20, 870.78)583.00 (425.96, 794.00)
Serum calcium, mg/dl
    Mean (SD)9.83 (0.80)9.88 (0.81)
    Median (Q1, Q3)9.80 (9.27, 10.27)9.83 (9.24, 10.49)
Serum phosphorus, mg/dl
    Mean (SD)6.23 (1.70)6.11 (1.50)
    Median (Q1, Q3)6.00 (5.10, 7.27)6.12 (5.00, 7.03)
Ca × P b, mg2/dl2
    Mean (SD)61.01 (16.45)60.27 (15.00)
    Median (Q1, Q3)58.99 (48.78, 71.46)60.18 (50.72, 69.91)
PTH ≤300 pg/ml + Ca×P ≤55 mg2/dl2, n (%)1 (<1)0 (0)
Co-existing diabetes, n (%)
    Yes93 (28)74 (29)
    No241 (72)181 (71)
Hypertension, n (%)
    Yes317 (95)242 (95)
    No17 (5)13 (5)
Coronary artery disease, n (%)
    Yes91 (27)65 (25)
    No243 (73)190 (75)
Congestive heart failure, n (%)
    Yes77 (23)39 (15)
    No257 (77)216 (85)
Myocardial infarction, n (%)
    Yes43 (13)36 (14)
    No291 (87)219 (86)
Peripheral vascular disease, n (%)
    Yes55 (16)47 (18)
    No279 (84)208 (82)
Cerebrovascular accident, n (%)
    Yes28 (8)30 (12)
    No306 (92)225 (88)
  • a Data unavailable for 19 subjects in original cinacalcet group and two subjects in original placebo group.

  • b Data unavailable for one subject in original cinacalcet group.