Table 1.
Baseline characteristics
| Characteristics | Belatacept Conversion, n=223 | CNI Continuation, n=223 |
|---|---|---|
| Age, yr | 53.4 (11.3) | 52.6 (11.7) |
| <65 | 184 (83%) | 186 (83%) |
| ≥65 | 39 (17%) | 37 (17%) |
| Sex | ||
| Men | 150 (67%) | 151 (68%) |
| Women | 73 (33%) | 72 (32%) |
| Race | ||
| White | 191 (86%) | 187 (84%) |
| Black | 24 (11%) | 24 (11%) |
| Asian | 1 (<1%) | 3 (1%) |
| Other | 7 (3%) | 9 (4%) |
| Geographic region | ||
| Europe | 97 (43%) | 92 (41%) |
| North America | 91 (41%) | 94 (42%) |
| South America | 35 (16%) | 37 (17%) |
| Prior transplants | ||
| 0 | 183 (82%) | 182 (82%) |
| 1 | 37 (17%) | 39 (17%) |
| 2 | 3 (1%) | 2 (1%) |
| Baseline eGFR based on laboratory values, ml/min per 1.73 m2 | ||
| <30 | 1 (<1%) | 0 |
| 30 to <45 | 87 (39%) | 83 (37%) |
| 45 to <75 | 131 (59%) | 136 (61%) |
| ≥75 | 4 (2%) | 4 (2%) |
| Mean | 49.6 (12.1) | 50.7 (11.6) |
| Mean (SD) baseline creatinine, mg/dl | 1.47 (0.35) | 1.44 (0.33) |
| Time from transplant to randomization, mo | 21.5 (14.0) | 21.6 (13.5) |
| Panel reactive antibodies, n/N (%) | ||
| ≤5% | 164/211 (78) | 160/212 (75) |
| >5% | 47/211 (22) | 52/212 (25) |
| Missing | 12/223 (5) | 11/223 (5) |
| Type of transplant donor | ||
| Living, related | 37 (17%) | 41 (18%) |
| Living, unrelated | 38 (17%) | 36 (16%) |
| Deceased donor | 148 (66%) | 146 (65%) |
| Primary cause of ESKD | ||
| Glomerular disease | 45 (20%) | 54 (24%) |
| Polycystic kidney disease | 43 (19%) | 45 (20%) |
| Diabetes mellitus | 38 (17%) | 30 (13%) |
| Hypertensive nephrosclerosis | 24 (11%) | 27 (12%) |
| Tubular and intestinal diseases | 9 (4%) | 9 (4%) |
| Renovascular and other vascular diseases | 8 (4%) | 6 (3%) |
| Congenital, rare familial, and metabolic disorders | 5 (2%) | 3 (1%) |
| Neoplasms | 0 | 1 (<1%) |
| Other | 50 (22%) | 48 (22%) |
| Not reported | 1 (<1%) | 0 |
| Specific disease history | ||
| Hypertension | 208 (93%) | 210 (94%) |
| Hypercholesterolemia | 100 (45%) | 104 (47%) |
| Type 2 diabetes mellitus | 60 (27%) | 63 (28%) |
| Type 1 diabetes mellitus | 14 (6%) | 4 (2%) |
| Donor-recipient HLA mismatches | ||
| 0–3 | 117 (52%) | 116 (52%) |
| 4–6 | 106 (48%) | 107 (48%) |
| Donor-recipient CMV serostatus | ||
| Positive-positive | 94 (42%) | 99 (44%) |
| Negative-negative | 47 (21%) | 39 (17%) |
| Negative-positive | 39 (17%) | 43 (19%) |
| Positive-negative | 39 (17%) | 42 (19%) |
| Unknown | 4 (2%) | 0 |
| Baseline immunosuppressants a | ||
| Tacrolimus + MMF | 118 (53%) | 125 (56%) |
| Tacrolimus + MPS | 82 (37%) | 73 (33%) |
| Cyclosporin + MMF | 13 (6%) | 15 (7%) |
| Cyclosporin + MPS | 10 (4%) | 10 (4%) |
Data are n (%) or mean (SD) unless otherwise stated. MMF, mycophenolate mofetil; MPS, mycophenolate sodium.
a
Baseline tacrolimus and cyclosporin concentrations at study entry are provided in Supplemental Table 2.