Table 1.
Baseline characteristics (FAS). The sequence groups did not show any relevant differences in terms of gender, age, height, or weight in the FAS or the PP analysis set
fasting→fed | fed→fasting | Total | ||
---|---|---|---|---|
(n = 15) | (n = 16) | (n = 31) | ||
Gender | ||||
Male | n (%) | 10 (66.7%) | 10 (62.5%) | 20 (64.5%) |
Female | n (%) | 5 (33.3%) | 6 (37.5%) | 11 (35.5%) |
Race | 15 (100%) | 16 (100%) | 31 (100%) | |
Caucasian | n (%) | |||
Age [years] | Mean (SD) | 48.5 (12.4) | 49.9 (14.0) | 49.3 (13.1) |
Range | 19–67 | 22–77 | 19–77 | |
Weight [kg] | Mean (SD) | 77.8 (14.3) | 78.8 (11.3) | 78.3 (12.6) |
Range | 55–102 | 59–102 | 55–102 | |
Height [cm] | Mean (SD) | 174.3 (11.6) | 173.9 (14.6) | 174.1 (13.0) |
Range | 160–200 | 143–200 | 143–200 | |
BMI [kg/m2] | Mean (SD) | 25.5 (3.4) | 26.3 (4.0) | 25.9 (3.7) |
Range | 21.3–30.2 | 19.8–32.2 | 19.8–32.2 | |
Smoking habits | 9 (60.0%) | 13 (81.3%) | 22 (71.0%) | |
Non-smoker | n (%) | |||
Ex-smoker | n (%) | 3 (20.0%) | – | 3 (9.7%) |
Smoker | n (%) | 1 (6.7%) | 3 (18.8%) | 4 (12.9%) |
Unknown | n (%) | 2 (13.3%) | – | 2 (6.5%) |
Time since last renal transplantation [years] | Median (Range) | 6.0 (2–28) | 6.5 (1–24) | 6.0 (1–28) |
Number of previous rejection episodes | ||||
0 | n (%) | 13 (86.7%) | 11 (68.8%) | 24 (77.4%) |
1 | n (%) | 1 (6.7%) | 5 (31.3%) | 6 (19.4%) |
2 | n (%) | 1 (6.7%) | – | 1 (3.2%) |
Time since end of last rejection episode [months] | Median (Range) | 36.1 (33–39) | 23.7 (6–63) | 36.1 (6–63) |
[n = 2] | [n = 4]a | [n = 6]a | ||
Duration of last rejection episode [days] | Median (Range) | 3.5 (3–4) | 4.0 (3–7) | 4.0 (3–7) |
[n = 2] | [n = 4]a | [n = 6]a | ||
Last daily ciclosporin dose applied before baseline [mg/kg/day] | Mean (SD) | 2.43 (0.707) | 2.31 (0.560) | 2.37 (0.628) |
a For one patient only year was given for start and end date of last rejection episode (1989). As a result, time since end and duration of last rejection were not assessable for this patient