Table 3.
Change from baseline to day 22 (end of treatment) in corrected serum calcium and intact parathyroid hormone
| Placebo (N=50) |
Genz-644470
|
Sevelamer carbonate
|
|||||
|---|---|---|---|---|---|---|---|
| 2.4 g/day (N=49) |
4.8 g/day (N=48) |
7.2 g/day (N=50) |
2.4 g/day (N=50) |
4.8 g/day (N=5I) |
7.2 g/day (N=48) |
||
| Corrected serum calcium* (mg/dL) | |||||||
| Baseline, mean (SD) | 8.90 (0.80) | 9.00 (0.84) | 8.97 (0.77) | 9.06 (0.81) | 9.15 (0.92) | 9.13 (0.67) | 8.78 (0.74) |
| Day 22/ET, mean (SD) | 8.86 (0.65) | 9.07 (0.88) | 9.24 (0.61) | 9.08 (0.86) | 9.11 (0.75) | 9.27 (0.71) | 8.92 (0.74) |
| Change from baseline to day | −0.05 (0.58) | 0.07 (0.52) | 0.26 (0.63) | 0.03 (0.47) | −0.04 (0.76) | 0.15 (0.49) | 0.14 (0.72) |
| 22/ET, mean (SD) [95% CI] | [−0.21 to 0.12] | [−0.08 to 0.22] | [0.08 to 0.44] | [−0.10 to 0.17] | [−0.26 to 0.17] | [0.01 to 0.28] | [−0.07 to 0.35] |
| Difference in group mean change compared with placebo | – | 0.11 | 0.31 | 0.08 | 0.00 | 0.19 | 0.18 |
| Intact parathyroid hormone (pg/mL) | |||||||
| Baseline, mean (SD) | 414.6 (304.22) | 348.6 (192.39) | 377.4 (233.54) | 434.7 (226.22) | 399.5 (246.89) | 396.4 (273.16) | 413.3 (241.51) |
| Day 22/ET, mean (SD) | 437.2 (331.74) | 342.1 (212.23) | 326.2 (193.36) | 395.7 (230.80) | 336.4 (187.97) | 309.5 (177.98) | 329.1 (212.43) |
| Change from baseline to day | 28.2 (298.70) | −6.5 (159.88) | −51.3 (144.03) | −44.1 (207.63) | −58.9 (170.2) | −88.2 (207.34) | −84.2 (169.38) |
| 22/ET, mean (SD) [95% CI] | [−57.6 to 114.0] | [−52.4 to 39.4] | [−93.1 to −9.4] | [−105.1 to 16.8] | [−108.0 to −9.9] | [−147.1 to −29.3] | [−133.3 to −35.0] |
| Difference in group mean change compared with placebo | – | −34.7 | −79.4 | −72.3 | −87.1 | −116.4 | −112.3 |
Notes:
*
Corrected calcium (mg/dL) = measured total Ca (mg/dL) + 0.8 (4.0 – serum albumin [g/dL]), where 4.0 represents the average albumin level in g/dL.
Abbreviations: ET, end of treatment or early termination; SD, standard deviation; CI, confidence interval.