Table 2.
Pharmacokinetic parameters
| 0-5 yr | 6-11 yr | 12-18 yr | |
|---|---|---|---|
| SRL + CsA | n = 3 | n = 8 | n = 14 |
| Cmax (ng/mL)* | 23.3 (10.3-30.7) | 23 (9.6-32.6) | 35.2 (12.0-51.0) |
| Trough (ng/mL) | 5.4 (4.6-8.8) | 9.4 (5.5-15.7) | 11.2 (2.8-35.7) |
| AUC (ngh/mL) | 224.1 (158.1-354.0) | 349.0 (207.2-546.1) | 418.0 (127.7-976.7) |
| MRT (h) | 9.7 (8.2-11.1) | 10.9 (8.7-11.9) | 10.2 (8.6-11.6) |
| aCL (L/h), mg/m2dose | 9.2 (5.3-14.9) | 4.4 (2.5-10.7) | 4.8 (1.5-7.3) |
| SRL + TCL | n = 4 (all b.i.d.) | n = 9 (5 b.i.d.) | n = 11 (5 b.i.d.) |
| Cmax (ng/mL) | |||
| q.d. only | NA | 27.2 (10.0-45.1) | 17 (6.1-36.3) |
| b.i.d. only | 23.8 (7.0-44.1) | 24.2 (13.7-45.3) | 13.7 (7.1-23.1) |
| Trough (ng/mL) | |||
| q.d. only | NA | 8.2 (4.3-9.7) | 6.4 (2.1-23.0) |
| b.i.d. only | 8.6 (4.4-11.9) | 9.4 (7.5-16.9) | 8.7 (5.1-12.0) |
| AUC (ng·h/mL) | |||
| q.d. only | NA | 321.9 (141.2-522.1) | 284.4 (85.9-452.2) |
| b.i.d. only | 136.7 (57.4-224.2) | 172.0 (106.2-270.8) | 112.5 (60.9-186.1) |
| MRT (h) | |||
| q.d. only* | NA | 9.6 (9.3-9.9) | 10.8 (10.0-12.2) |
| b.i.d. only | 5.1 (4.8-5.4) | 4.9 (4.7-5.3) | 5.3 (4.9-6.1) |
| aCL (L/h), mg/m2dose | |||
| q.d. only | NA | 7.8 (4.1-14.5) | 10.0 (6.1-16) |
| b.i.d. only | 26.0 (14.2-47.9) | 10.6 (7.5-20.3) | 15.4 (9.7-18.1) |
| SRL without CNI | n = 5 | n = 1 | n = 11 |
| aCL (L/h), mg/m2dose* | 49.2 (32.3-71.9) | 27.1 | 27.4 (7.9-45.1) |
Values are expressed as median (range). NA = not applicable.
*
p-value < 0.05. The Kruskal test was used for three-way comparisons and the Mann-Whitney test was used for two-way comparisons.