Table 1.
Patient demographics and baseline characteristics—mITT set
| LCPT N = 162 | Tacrolimus twice daily N = 162 | p-Value | |
|---|---|---|---|
| Age (years), mean (SD) | 50.4 (11.75) | 50.3 (13.46) | 0.965 |
| Sex | 0.098 | ||
| Male | 116 (71.6%) | 101 (62.3%) | |
| Female | 46 (28.4%) | 61 (37.7) | |
| Race | 0.836 | ||
| White | 120 (74.1%) | 116 (71.6%) | |
| Black | 35 (21.6%) | 34 (21.0%) | |
| Asian | 3 (1.9%) | 3 (1.9%) | |
| Other | 4 (2.5%) | 9 (5.5%) | |
| Previous rejection for the current graft, n (%) | 20 (12.3%) | 23 (14.2%) | 0.744 |
| Donor type | 0.244 | ||
| Living | 62 (38.3%) | 51 (31.5%) | |
| Deceased | 100 (61.7%) | 111 (68.5%) | |
| Number of HLA mismatches | 0.539 | ||
| 0 | 15 (9.3%) | 15 (9.3%) | |
| 1 | 10 (6.2%) | 8 (4.9%) | |
| 2 | 18 (11.1%) | 11 (6.8%) | |
| ≥3 | 119 (73.5%) | 128 (79.0%) | |
| Subjects who had a previous transplant other than the current transplant, n (%) | 22 (13.6%) | 19 (11.7%) | 0.739 |
| Pretransplant diabetes, n (%) | 63 (38.9%) | 59 (36.4%) | 0.647 |
| PRA (%), mean (SD) | 10.4 (24.09) | 8.9 (19.47) | 0.567 |
| Preconversion Prograf total daily dose (mg) | 6.1 (3.90) | 5.3 (3.35) | 0.063 |
| PRA (%), median | 0 | 0 | |
| PRA <5%, n (%) | 106 (65.4%) | 100 (61.7%) | |
| Months from transplant to enrollment, mean (SD) | 25.9 (16.7) | 22.1 (15.2) | 0.034 |
HLA = human leukocyte antigen; PRA = panel-reactive antibody.