Table 1.
Baseline characteristics of the Efficacy Limiting Toxicity Elimination Symphony Study and the Fixed-Dose Concentration-Controlled Study populations
| Variable | ELITE Symphony (n=1190) | FDCC (n=630) | P Value |
|---|---|---|---|
| Recipient age (yr) | 47.3 (35.4–57.0) | 43.9 (33.0–57.0) | 0.07 |
| Men, no. (%) | 772 (64.9) | 383 (60.8) | 0.09 |
| Race, no. (%) | <0.001 | ||
| White | 1104 (92.8) | 503 (79.8) | |
| Black | 21 (1.8) | 23 (3.7) | |
| Asian | 11 (0.9) | 35 (5.6) | |
| Other | 54 (4.5) | 69 (11.0%) | |
| Pretransplant diabetes mellitus, no. (%) | 127 (10.7) | 37 (5.9) | 0.001 |
| Donor type, no. (%) | <0.001 | ||
| Living | 424 (35.6) | 149 (23.7) | |
| Deceased nonextended criteria donor | 556 (46.8) | 397 (63.0) | |
| Deceased extended criteria donor | 209 (17.6) | 84 (13.3) | |
| Donor age (yr) | 47 (35.8–57.0) | 43.3 (30.3–56.0) | 0.07 |
| Cold ischemia time (h) | 11.3 (1.4–18.0) | 12.5 (4.0–18.0) | <0.001 |
| Cytomegalovirus status, no. (%) | |||
| D+/R− | 158 (13.3) | 98 (15.6) | 0.20 |
| HLA mismatches, no. (%) | 0.02 | ||
| 0 | 102 (8.9) | 29 (4.6) | |
| 1 | 83 (7.3) | 48 (7.6) | |
| 2 | 193 (16.9) | 102 (16.2) | |
| 3 | 370 (32.3) | 197 (31.3) | |
| 4 | 208 (18.2) | 135 (21.4) | |
| 5 | 132 (11.5) | 88 (14.0) | |
| 6 | 56 (4.9) | 31 (4.9) | |
| Immunosuppression, no. (%) | NA | ||
| Standard-dose CsA, MMF, steroids | 390 (32.8) | ||
| Daclizumab, low-dose CsA, MMF, steroids | 399 (33.5) | ||
| Daclizumab, low-dose Tac, MMF, steroids | 401 (33.7) |
Recipient and donor ages and cold ischemia time are reported as median (25th–75th percentiles). ELITE Symphony, Efficacy Limiting Toxicity Elimination Symphony Study; FDCC, Fixed-Dose Concentration-Controlled Study; D+/R–, donor seropositive and recipient seronegative; NA, not applicable; CsA, cyclosporin A; MMF, mycophenolate mofetil; Tac, tacrolimus.