Demographic and baseline characteristics of the extension study population
| CNI-free (n = 41) | CNI (n = 40) | |
|---|---|---|
| Recipient age (years), mean (SD) | 53.0 (10.3) | 52.0 (10.9) |
| Male gender, n (%) | 24 (58.5) | 25 (62.5) |
| Body mass index (kg/m2), mean (SD) | 26.0 (4.4) | 26.6 (3.9) |
| Primary reason for transplantation (n, %) | ||
| Alcoholic cirrhosis | 14 (34.1) | 13 (32.5) |
| Hepatitis B | 3 (7.3) | 3 (7.5) |
| Hepatitis C | 1 (2.4) | 5 (12.5) |
| Sclerosing cholangitis | 2 (4.9) | 2 (5.0) |
| Cryptogenic cirrhosis | 4 (9.8) | 2 (5.0) |
| Primary biliary cirrhosis | 0 (0.0) | 2 (5.0) |
| Other | 17 (41.5) | 13 (32.5) |
| MELD score (points), mean (SD) | 16.6 (9.3) | 14.0 (6.5) |
| Time from liver transplant to randomization (days), mean (SD) | 46.7 (11.6) | 42.1 (11.5) |
| Type of transplant, n (%) | ||
| Complete liver | 36 (87.8) | 36 (90.0) |
| Split liver | 5 (12.2) | 4 (10.0) |
| Donor type, n (%) | ||
| Deceased heart beating | 39 (95.1) | 38 (95.0) |
| Living related | 2 (4.9) | 1 (2.5) |
| Living unrelated | 0 (0.0) | 1 (2.5) |
| Donor hepatitis C positive, n (%) | 0 (0.0) | 4 (10.0) |
| BPAR during core study, n (%) | 8 (19.5) | 1 (2.5) |
*p = 0.029.
BPAR, biopsy-proven acute rejection; CNI, calcineurin inhibitor; MELD, Model for End-Stage Liver Disease; SD, standard deviation.