Table 3.
Changes from baseline in serum phosphorus, calcium and calcium-phosphorus product levels
| Treatment arm | Phosphorus, mmol/L | Calcium, mmol/L | Calcium-phosphorus, mmol2/L2 |
|---|---|---|---|
| Per-protocol set 1 – change from baseline to week 8a | |||
| CC (n = 17) | |||
| Baseline | 2.165 (0.093) | 2.319 (0.052) | 4.904 (0.247) |
| Week 8b | 1.633 (0.141) | 2.384 (0.077) | 3.917 (0.412) |
| Change from baselinec | −0.520 (0.179) | 0.058 (0.055) | −0.966 (0.408) |
| LC (n = 17) | |||
| Baseline | 2.188 (0.087) | 2.371 (0.065) | 4.729 (0.350) |
| Week 8 | 1.721 (0.107) | 2.362 (0.052) | 4.060 (0.256) |
| Change from baseline | −0.467 (0.131) | −0.009 (0.057) | −0.669 (0.383) |
| Per-protocol set 2 – change from baseline by weekc | |||
| LC (n = 34; n varies by week and measurement) | |||
| Baseline | 2.274 (0.072) | 2.426 (0.041) | 5.275 (0.231) |
| Week 8 | 1.940 (0.098) | 2.424 (0.037) | 4.698 (0.236) |
| Change from baseline | −0.334 (0.104) | − 0.001 (0.036) | − 0.577 (0.246) |
| Week 12d | 1.833 (0.076) | 2.359 (0.043) | 4.341 (0.210) |
| Change from baselined | −0.416 (0.091) | −0.045 (0.048) | −0.783 (0.254) |
| Week 16e | 1.941 (0.114) | 2.359 (0.060) | 4.580 (0.277) |
| Change from baselinee | −0.314 (0.128) | −0.034 (0.053) | −0.575 (0.302) |
| Week 20f | 1.898 (0.085) | 2.397 (0.055) | 4.660 (0.287) |
| Change from baselinef | −0.316 (0.106) | 0.003 (0.051) | −0.362 (0.271) |
| Week 24g | 1.884 (0.138) | 2.371 (0.051) | 4.521 (0.349) |
| Change from baselineg | −0.322 (0.136) | −0.010 (0.045) | −0.578 (0.346) |
| Week 28h | 1.953 (0.125) | 2.381 (0.074) | 4.658 (0.331) |
| Change from baselineh | −0.236 (0.149) | 0.049 (0.062) | −0.326 (0.377) |
| Week 32i | 2.008 (0.142) | 2.210 (0.061) | 4.484 (0.345) |
| Change from baselinei | −0.143 (0.156) | −0.127 (0.077) | −0.570 (0.362) |
All data are presented as mean (SEM). Per-protocol set 1 included all patients who received CC for 8 weeks during part 2, followed by a washout period and then LC for at least 8 weeks during part 2, and who had serum phosphorus data available for analysis. Per-protocol set 2 included all patients who received LC for at least 8 weeks during part 2 and/or part 3, and who had serum phosphorus data available for analysis. Patients with missing data were excluded from these analyses
a One patient did not complete the 8 weeks of CC treatment and progressed straight to the 8 weeks of LC treatment
b n = 16
c Weeks listed are exposure to LC and not the scheduled visit
d Phosphorus, n = 30; calcium, n = 28; calcium-phosphorus product, n = 28
e Phosphorus, n = 27; calcium, n = 26; calcium-phosphorus product, n = 26
f Phosphorus, n = 25; calcium, n = 22; calcium-phosphorus product, n = 22
g Phosphorus, n = 23; calcium, n = 22; calcium-phosphorus product, n = 22
h n = 20
i n = 13
CC calcium carbonate, LC lanthanum carbonate, SEM standard error of the mean