Table 1.
Baseline demographics and characteristics of CC- and LC-treated patients
| Characteristic | Part 1 (Safety analysis set 1) | Part 2 (Safety analysis set 2) | Parts 2 and 3 combined (Safety completer set) | |
|---|---|---|---|---|
| LC (n = 20) |
CC (n = 53) |
LC (n = 51) |
LC (n = 46) |
|
| Age, years, mean (SD) | 13.1 (2.7) | 13.1 (2.8) | 13.6 (2.7) | 13.8 (2.6) |
| Age group, years, mean (SD)a | ||||
| < 10b | 1 (5.0) | 3 (5.7) | 2 (3.9) | 2 (4.3) |
| 10 to 11 | 4 (20.0) | 11 (20.8) | 9 (17.6) | 6 (13.0) |
| 12 to 17 | 15 (75.0) | 39 (73.6) | 40 (78.4) | 38 (82.6) |
| Sex, n (%) | ||||
| Male | 10 (50.0) | 29 (54.7) | 30 (58.8) | 27 (58.7) |
| Female | 10 (50.0) | 24 (45.3) | 21 (41.2) | 19 (41.3) |
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 0 (0.0) | 5 (9.4) | 4 (7.8) | 4 (8.7) |
| Non-Hispanic or Latino | 20 (100) | 48 (90.6) | 47 (92.2) | 42 (91.3) |
| Race, n (%) | ||||
| White | 19 (95.0) | 52 (98.1) | 50 (98.0) | 45 (97.8) |
| Non-white | 1 (5.0) | 1 (1.9) | 1 (2.0) | 1 (2.2) |
| Weight, kg, mean (SD) | 41.9 (16.5) | 38.7 (15.1) | 41.7 (15.9) | 42.4 (16.1) |
| Height, cm, mean (SD) | 149.2 (19.3) | 145.7 (19.7) | 149.1 (19.0) | 149.9 (19.1) |
| Body mass index, kg/m2, mean (SD) | 18.1 (3.4) | 17.7 (3.2) | 18.3 (3.9) | 18.4 (4.0) |
| Dialysis mode, n (%) | ||||
| Hemodialysis | 12 (60.0) | 30 (56.6) | 29 (56.9) | 28 (60.9) |
| Peritoneal dialysis | 8 (40.0) | 23 (43.4) | 22 (43.1) | 18 (39.1) |
Safety analysis set 1 included all patients who received at least one dose of LC in part 1 and attended at least one safety follow-up visit. Safety analysis set 2 included all patients who received at least one dose of CC or LC in part 2 and/or part 3 of the study and attended at least one safety follow-up visit. The safety completer set included all patients who received LC for at least 8 weeks in part 2 and/or part 3 of the study
a Age group was calculated as the difference between the date of birth and the date that informed consent/assent was received
b Patient demographics are presented for patients < 10 years old who were included in the study before the protocol amendment, in which the inclusion criteria of 6 months to < 18 years old was adjusted to 10 years to < 18 years old
CC calcium carbonate, LC lanthanum carbonate, SD standard deviation