TABLE 1.
Baseline characteristics (n = 92)
| ER‐tacrolimus (n = 47) | LCP‐tacrolimus (n = 45) | |
|---|---|---|
| Male sex (%) | 33 (70.2) | 27 (60.0) |
| Age in years, mean (SD) | 56.8 (13.5) | 50.6 (14.7) |
| BMI, mean (SD) | 27.0 (4.7) | 27.5 (4.1) |
| Ethnicity (%) | ||
| White | 41 (87.2) | 41 (91.1) |
| Asian | 0 | 1 (2.2) |
| Black | 4 (8.5) | 2 (4.4) |
| Other | 2 (4.3) | 1 (2.2) |
| Transplantation (%) | ||
| First | 34 (72.3) | 37 (82.2) |
| Second | 11 (23.4) | 6 (13.3) |
| ≥3 | 2 (4.3) | 2 (4.4) |
| Donor category (%) | ||
| Living | 33 (70.2) | 38 (84.4) |
| Deceased | 14 (29.8) | 7 (15.6) |
| Time from transplantation to enrollment, months, median (IQR) | 42.8 (20.5–78.3) | 50.0 (17.7–99.8) |
| eGFR (MDRD) in ml/min/1.73 m2 at baseline, mean (SD) | 49.9 (17.0) | 48.3 (14.6) |
| Concomitant immunosuppressive therapy (%) | ||
| Azathioprine | 1 (2.1) | 0 |
| Mycophenolate mofetil | 22 (46.8) | 16 (35.6) |
| Prednisolone | 10 (21.3) | 17 (37.8) |
| Azathioprine + prednisolone | 2 (4.3) | 3 (6.7) |
| Mycophenolate mofetil + prednisolone | 12 (25.5) | 9 (20.0) |
| CYP3A5 (%) | ||
| Expressor | 11 (23.4) | 10 (22.2) |
| *1/*1 | 0 | 1 |
| *1/*3 | 10 | 9 |
| *1/*6 | 1 | 0 |
| Nonexpressor (*3/*3) | 30 (63.8) | 29 (64.4) |
| Unknown | 6 (12.8) | 6 (13.3) |
Abbreviations: BMI, body mass index; eGFR, estimated glomerular filtration rate; ER, extended release; IQR, interquartile range; LCP, LifeCyclePharma; MDRD, modification of diet in renal disease.