Table 1.
Clinical characteristics of the DART analysis groups
| Clinical Characteristic | Training | Validation | ||||||
|---|---|---|---|---|---|---|---|---|
| Healthy Stable AlloSure <1% | Rejection | P Value | Nonrejection | Healthy Stable | Protocol Nonrejection | Rejection |
P Value (Nonrejection versus Rejection) |
|
| Patients, N | 22 | 16 | 44 | 20 | 19 | 16 | ||
| Samples, N | 38 | 18 | 47 | 22 | 29 | 18 | ||
| Race, n (%) | 0.35 | 0.63 | ||||||
| Black | 13 (34) | 8 (44) | 14 (30) | 0 | 8 (28) | 4 (22) | ||
| White | 21 (55) | 9 (50) | 25 (53) | 15 (68) | 19 (66) | 13 (72) | ||
| Native | 0 | 1 (6) | 0 | 0 | 1 (4) | 0 | ||
| Hispanic/Latino | 3 (8) | 0 | 5 (11) | 4 (18) | 1 (4) | 1 (6) | ||
| Asian | 0 | 0 | 1 (2) | 1 (5) | 0 | 0 | ||
| Other | 1 (3) | 0 | 2 (4) | 2 (9) | 0 | 0 | ||
| Sex, n (%) | 0.88 | 0.31 | ||||||
| Men | 24 (63) | 11 (61) | 30 (64) | 14 (64) | 21 (72) | 9 (50) | ||
| Women | 14 (37) | 7 (39) | 17 (36) | 8 (36) | 8 (28) | 9 (50) | ||
| Age at enrollment, yr, mean±SD | 48.8±13.7 | 47.9±17.8 | 0.85 | 50.9±14.5 | 54.9±11.8 | 53.8±12.7 | 39.4±10.9 | 0.001 |
| Post-transplant, d, mean±SD | 94.5±55.3 | 1091±1071 | <0.001 | 965±1360 | 244±200 | 242±192 | 1322±1213 | 0.32 |
| CMV serologic status, n (%) | 0.05 | 0.07 | ||||||
| D−/R+ | 10 (26) | 3 (17) | 13 (28) | 7 (32) | 12 (41) | 3 (17) | ||
| D+/R+ | 14 (37) | 3 (17) | 14 (30) | 7 (32) | 7 (24) | 3 (17) | ||
| D−/R− | 7 (18) | 2 (11) | 8 (17) | 3 (14) | 7 (24) | 4 (22) | ||
| D+/R− | 4 (10) | 3 (17) | 5 (11) | 2 (9) | 3 (10) | 0 | ||
| Unknown | 3 (8) | 7 (39) | 7 (15) | 3 (14) | 0 | 8 (44) | ||
| Donor type, n (%) | 0.47 | 0.12 | ||||||
| Deceased | 21 (55) | 13 (72) | 28 (60) | 13 (59) | 15 (52) | 11 (61) | ||
| Living, unrelated | 4 (10) | 1 (6) | 14 (30) | 3 (14) | 8 (28) | 2 (11) | ||
| Living, related | 13 (34) | 4 (22) | 5 (11) | 6 (27) | 6 (20) | 5 (28) | ||
| Creatinine, mg/dl, mean±SD | 1.46±0.53 | 2.47±1.15 | <0.001 | 2.27±1.49 | 1.36±0.53 | 1.61±0.57 | 2.83±0.91 | 0.08 |
| eGFR, ml/min per 1.73 m2, mean±SD | 55.0±14.9 | 33.6±13.1 | <0.001 | 38.9±19.8 | 56.3±19.6 | 48.2±13.2 | 25.9±11.3 | 0.002 |
| HLA class 1, n mismatches (A, B), mean±SD | 2.7±1.1 | 3.1±1.3 | 0.30 | 2.5±1.3 | 2.1±1.1 | 2.9±1.2 | 1.7±1.1 | 0.02 |
| HLA class 2, n mismatches (DR), mean±SD | 1.2±0.6 | 1.2±0.5 | 0.95 | 1.1±0.8 | 1.1±0.8 | 1.2±0.7 | 0.9±0.8 | 0.32 |
| PRA class I (%) | ||||||||
| Mean PRA | 1.72 | 1.73 | >0.99 | 24.1 | 10.8 | 9.03 | 13.4 | 0.17 |
| Samples | 36 | 15 | 39 | 16 | 29 | 15 | ||
| PRA class II (%) | ||||||||
| Mean PRA | 4.67 | 18.1 | 0.12 | 14.8 | 10.9 | 2.9 | 20.9 | 0.52 |
| Samples | 36 | 14 | 39 | 16 | 29 | 15 | ||
| Induction patients, n (%) | 0.05 | 0.46 | ||||||
| ATG | 2 (9) | 8 (50) | 9 (21) | 2 (10) | 0 | 5 (31) | ||
| Alemtuzumab | 3 (14) | 3 (19) | 9 (21) | 1 (5) | 0 | 2 (13) | ||
| Basiliximab | 2 (9) | 0 | 0 | 1 (5) | 0 | 1 (6) | ||
| Other | 3 (14) | 3 (19) | 8 (18) | 2 (10) | 0 | 3 (19) | ||
| None | 14 (65) | 5 (31) | 23 (52) | 15 (75) | 19 (100) | 8 (50) | ||
| Immunosuppression samples, n (%) | 0.26 | 0.52 | ||||||
| Cyclosporin | 2 (5) | 2 (11) | 5 (11) | 1 (4) | 0 | 2 (11) | ||
| Tacrolimus | 35 (92) | 16 (89) | 38 (81) | 20 (20) | 27 (93) | 15 (83) | ||
| Mycophenolate | 34 (90) | 14 (78) | 40 (85) | 20 (91) | 28 (97) | 15 (83) | ||
| Prednisone | 17 (45) | 14 (78) | 28 (60) | 16 (73) | 10 (34) | 13 (72) | ||
| Rapamycin | 2 (5) | 1 (6) | 3 (6) | 0 | 0 | 2 (11) | ||
| Azathioprine | 2 (5) | 1 (6) | 3 (6) | 0 | 1 (3) | 1 (6) | ||
| Belatacept | 1 (3) | 0 | 2 (4) | 0 | 2 (7) | 0 | ||
| Other | 0 | 3 (17) | 0 | 0 | 0 | 2 (11) | ||
CMV, cytomegalovirus; D−/R+, donor negative/recipient positive; PRA, panel-reactive antibody; ATG, antithymocyte globulin.