Table 2.

Key baseline laboratory characteristics by occurrence of calcific uremic arteriolopathy adverse event during the study (safety analysis set)

CharacteristicCUA (n=25)No CUA (n=3858)P Valuea
Placebo (N1=19)Cinacalcet (N1=6)Total (N1=25)Placebo (N1=1916)Cinacalcet (N1=1942)Total (N1=3858)
Intact PTH (pg/ml)515 (285, 1339)857 (344, 2755)579 (333, 2121)692 (364, 1693)694 (363, 1699)693 (364, 1695)0.18
Corrected calcium (mg/dl)9.9 (9.0, 10.6)10.5 (9.7, 10.8)10.1 (9.5, 10.6)9.8 (9.0, 10.7)9.8 (9.0, 10.7)9.8 (9.0, 10.7)0.08
Phosphorus (mg/dl)6.4 (4.6, 9.5)6.6 (4.8, 8.2)6.4 (4.8, 8.8)6.2 (4.9, 8.4)6.3 (4.9, 8.3)6.2 (4.9, 8.4)0.45
25(OH)D (ng/ml)14.5 (6, 38)20.5 (14, 26)15 (8, 28)18 (8, 39)17 (8, 37)17 (8, 37)0.44
Alkaline phosphatase (U/L)91 (59, 151)129 (59, 500)91 (59, 166)108 (65, 232)107 (64, 248)108 (65, 24)
Bone alkaline phosphatase (µg/L)17.53 (9.60, 32.89)31.51 (10.29, 139.66)20.96 (10.21, 38.21)22.92 (11.56, 66.81)23.09 (11.52, 70.52)23.02 (11.53, 68.11)0.12
N-telopeptide (nmol/L)141.6 (45.6, 280.4)620.9 (134.4, 1414.1)196.2 (52.8, 692.8)249.6 (79.3, 821.0)261.0 (81.0, 925.4)255.3 (80.6, 884.9)0.13
Hemoglobin (g/dl)11.9 (8.4, 13.2)11.7 (9.1, 12.7)11.7 (9.1, 12.7)11.8 (10.0, 13.8)11.7 (10.0, 13.5)11.8 (10.0, 13.6)0.62
Albumin (g/dl)3.6 (3.1, 4.0)3.5 (3.3, 4.2)3.6 (3.1, 4.0)3.7 (3.2, 4.1)3.7 (3.2, 4.1)3.7 (3.2, 4.1)0.30
Total protein (g/dl)7.0 (6.2, 7.7)6.8 (5.8, 7.1)6.9 (6.2, 7.5)7.0 (6.3, 7.7)6.9 (6.3, 7.7)6.9 (6.3, 7.7)0.44
Bicarbonate (mEq/L)18.8 (14.4, 26.0)23.3 (18.9, 24.9)19.3 (14.7, 24.9)20.4 (15.8, 25.6)20.3 (15.7, 25.4)20.3 (15.7, 25.5)0.63
Creatinine (mg/dl)9.7 (4.7, 13.6)10.9 (7.7, 12.8)10.0 (6.4, 13.2)9.9 (6.7, 13.9)9.9 (6.6, 13.9)9.9 (6.7, 13.9)0.77
  • Values are expressed as median (10%, 90% percentile). N1 refers to number of patients in the safety analysis set; n percentages are based on N1. CUA, calcific uremic arteriolopathy; PTH, parathyroid hormone; 25(OH)D, 1,25-dihydroxyvitamin D.

  • a Wilcoxon rank-sum test was used for continuous variables and chi-square test was used for categorical variables. Comparisons are between patients who experienced a CUA adverse event compared with those who did not.