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Table 1 Baseline demographics and characteristics of CC- and LC-treated patients

From: An open-label phase 2 trial to assess the efficacy, safety and pharmacokinetics of lanthanum carbonate in hyperphosphatemic children and adolescents with chronic kidney disease undergoing dialysis

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)

  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
  2. Age group was calculated as the difference between the date of birth and the date that informed consent/assent was received
  3. 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
  4. CC calcium carbonate, LC lanthanum carbonate, SD standard deviation