TABLE 1.
Clinical Characteristics: Discovery (CTOT14) and Validation (BUMC) Cohorts
| CTOT14-D* |
CTOT14-P* |
BUMC-D† |
BUMC-P† |
|||
|---|---|---|---|---|---|---|
| Variable | N = 28 | N = 32 | P Value | N = 18 | N = 32 | P Value |
| At LT | ||||||
| Age at enrollment (years) | 52.5 (12.2) | 54.1 (8.7) | 0.575 | 54.33 (9.3) | 44.31 (11.0) | 0.002 |
| Sex (% male) | 17 (60.7%) | 25 (78.1%) | 0.142 | 10 (55.6) | 22 (68.8) | 0.531 |
| Race (% white) | 22 (78.6%) | 27 (84.4%) | 0.562 | 17 (94.4) | 26 (81.2) | 0.386 |
| HCV as listing diagnosis‡ | 4 (14.3%) | 11 (34.4%) | 0.073 | 1 (5.6%) | 14 (43.8%) | 0.005 |
| Hypertension | 6 (21.4%) | 8 (25.0%) | 0.744 | 1 (5.6) | 2 (6.2) | >0.999 |
| Diabetes | 7 (25.0%) | 7 (21.9%) | 0.775 | 2 (11.1) | 4 (12.5) | >0.999 |
| Month 3 post-LT | ||||||
| CNI therapy, n (%) | 24 (85.7%) | 31 (96.9%) | 0.175 | 18 (100) | 32 (100) | >0.999 |
| Alanine aminotransferase (U/L) | 44.1 (77.8) | 45.5 (46.71) | 0.304 | 39.5 (24.5) | 39.5 (29.1) | 0.997 |
| Alkaline phosphatase (U/L) | 132.6 (177.1) | 139.0 (121.1) | 0.740 | 105.1 (35.2) | 90.4 (33.1) | 0.131 |
| Total bilirubin (mg/dL) | 0.9 (0.9) | 0.7 (0.89) | 0.733 | 0.54 (.31) | 0.58 (0.33) | 0.708 |
| mGFR (mL/min/1.73 m2) | n/a | n/a | 80.2 (16.74) | 82.1 (26.8) | 0.363 | |
| eGFR (mL/min/1.73 m2) | 81.2 (17.6) | 81.3 (16.23) | 0.941 | 80.2 (16.7) | 85.9 (24.5) | 0.776 |
| Year 1 post-LT | ||||||
| CNI therapy, n (%) | 22 (78.6%) | 28 (87.5%) | 0.491 | 18 (100%) | 32 (100%) | >0.999 |
| Mycophenolic acid, n (%) | 9 (32.1%) | 8 (25.0%) | 0.540 | 8 (44.4%) | 16 (50%) | 0.706 |
| mTOR-inhibitor therapy, n (%) | 4 (14.3%) | 7 (21.9%) | 0.449 | 3 (16.7%) | 1 (3.1%) | 0.127 |
| mGFR (mL/min/1.73 m2) | n/a | n/a | 54.7 (16.1) | 98.3 (20.7) | <0.001 | |
| eGFR (mL/min/1.73 m2) | 62.5 (16.7) | 84.6 (16.0) | <0.001 | 47.0 (11.6) | 91.0 (24.2) | <0.001 |
| At year 5 post-LT | n/a | n/a | ||||
| CNI therapy, n (%) | n/a | n/a | 16 (88.8%) | 32 (100%) | 0.125 | |
| Mycophenolic acid or azathioprine, n (%) | n/a | n/a | 9 (50%) | 15 (83.3%) | 0.831 | |
| mTOR-inhibitor therapy, n (%) | n/a | n/a | 6 (33.3%) | 0 (0%) | 0.0012 | |
| mGFR (mL/min/1.73 m2) | n/a | n/a | 33.9 (7.6) | 94.7 (22.7) | <0.001 | |
| eGFR (mL/min/1.73 m2) | n/a | n/a | 39.3 (14.1) | 84.6 (28.9) | <0.001 | |
*
Defined by GFR > 60 at month 3 and then >10% deterioration in GFR (Diminished) vs. ≤10% (Preserved) at year 1.
†
Defined by GFR > 60 at month 3, >10% deterioration in GFR (Diminished) vs. ≤10% (Preserved) at year 1, and then GFR < 45 (Diminished) vs. GFR ≥60 mL/min (Preserved) up to 5 years.
‡
Two in the CTOT14-D group and 4 in the CTOT14-P group were HCV nonviremic in the study period. None of the BUMC patients were HCV nonviremic.
Abbreviation: n/a, not applicable.