Table 3.
Serum calcium and magnesium baseline values, changes from baseline values at Week 25 and number of visits > ULN and <LLN, as well as above and below K/DOQI range (for Ca) (FAS, N = 244)
| Parameter | CaMg |
Sevelamer-HCl |
P-value | ||
|---|---|---|---|---|---|
| N | (Mean ± SD) | N | (Mean ± SD) | ||
| Ionized calcium (mmol/L) | |||||
| Baseline | 113 | 1.071 ± 0.1608 | 112 | 1.076 ± 0.1306 | |
| Week 25 | 120 | 1.104 ± 0.1210 | 119 | 1.113 ± 0.1063 | |
| Change at Week 25 | 112 | 0.036 ± 0.1702 | 110 | 0.036 ± 0.1369 | |
| Treatment difference (LS-means) [confidence interval] | −0.0015 [−0.0294, 0.0264] | 0.9173 | |||
| Total serum calcium (mmol/L) | |||||
| Baseline | 122 | 2.148 ± 0.2288 | 122 | 2.185 ± 0.1820 | |
| Week 25 | 122 | 2.219 ± 0.1565 | 122 | 2.189 ± 0.1574 | |
| Change at Week 25 | 122 | 0.071 ± 0.1790 | 122 | 0.004 ± 0.1522 | |
| Treatment difference (LS-means) [confidence interval] | 0.0477 [0.0162, 0.0793] | 0.0032 | |||
| No. of visits Ca > ULN (2.6 mmol/L) | 122 | 0.11 ± 0.460 | 122 | 0.07 ± 0.563 | 0.2374 |
| No. of visits Ca < LLN (2.2 mmol/L) | 122 | 4.31 ± 3.695 | 122 | 4.55 ± 3.827 | 0.6839 |
| No. of visits Ca > K/DOQI range (2.37 mmol/L) | 122 | 1.81 ± 2.881 | 122 | 1.25 ± 2.412 | 0.1005 |
| No. of visits Ca < K/DOQI range (2.10 mmol/L) | 122 | 2.23 ± 2.911 | 122 | 2.38 ± 3.178 | 0.4809 |
| Serum magnesium (mmol/L) | |||||
| Baseline | 122 | 0.993 ± 0.1544 | 122 | 0.996 ± 0.1613 | |
| Week 25 | 122 | 1.297 ± 0.2547 | 122 | 1.039 ± 0.1851 | |
| Change at Week 25 | 122 | 0.304 ± 0.2285 | 122 | 0.043 ± 0.1453 | |
| Treatment difference (LS-means) [confidence interval] | 0.2597 [0.2137, 0.3056] | <0.0001 | |||
| No. of visits Mg > ULN (1.05 mmol/L) | 122 | 7.86 ± 2.514 | 122 | 4.10 ± 3.797 | <0.0001 |
| No. of visits Mg < LLN (0.65 mmol/L) | 122 | 0.04 ± 0.237 | 122 | 0.04 ± 0.237 | 1.0000 |