Table 2.
Key baseline laboratory characteristics by occurrence of calcific uremic arteriolopathy adverse event during the study (safety analysis set)
| Characteristic | CUA (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.