Table 1.
Patient characteristics
| Model building group 1 (n = 237) | Model building group 2 (n = 100) | Model validation group (n = 304) | |
|---|---|---|---|
| Recipient sex | |||
| Male | 148 (62.4%) | 56 (56.0%) | 200 (65.8%) |
| Age of recipient (years) | 58.5 (19.4–79.4) | 54.0 (15.0–77.0) | 52.0 (17.0–83.0) |
| Ethnicity | |||
| Caucasian | 186 (78.4%) | 78 (78.0%) | 304 (100%) |
| Asian | 23 (9.7%) | 8 (8.0%) | 0 (0%) |
| African descent | 23 (9.7%) | 1 (1.0%) | 0 (0%) |
| Other | 5 (2.1%) | 13 (13.0%) | 0 (0%) |
| Bodyweight (kg) * | 79.4 (37.6–132.0) | 74.0 (40.0–114.0) | 68.0 (40.0–106.0) |
| Height (cm) * | 183 (145–203) | 172 (141–195) | 166 (145–190) |
| Body mass index (kg m –2 ) | 25.8 (17.2–42.2) | 24.8 (15.6–38.2) | 24.7 (16.3–44.1) |
| Body surface area (m 2 ) | 2.03 (1.24–2.66) | 1.90 (1.33–2.48) | 1.78 (1.18–2.36) |
| Ideal bodyweight (kg) | 68.3 (46.8–89.8) | 65.3 (41.7–83.9) | 60.9 (45.7–80.2) |
| Lean bodyweight (kg) | 64.0 (33.1–85.3) | 55.9 (33.6–81.7) | 51.4 (34.9–76.3) |
| Fat mass (kg) | 21.7 (12.0–44.0) | 26.0 (14.1–49.5) | 25.5 (11.3–50.2) |
| Laboratory measurements * | |||
| Haematocrit (l l –1 ) | 0.34 (0.15–0.80) | 0.34 (0.24–0.45) | 0.33 (0.18–0.59) |
| Creatinine (μmol l –1 ) | 137 (38–1885) | 124 (62–920) | 139 (47–1284) |
| ASAT (U l –1 ) | 21 (<5–662) | Unknown | Unknown |
| Albumin (g l –1 ) | 42 (12–57) | Unknown | Unknown |
| Bilirubin (μmol l –1 ) | 6 (<2–305) | Unknown | Unknown |
| Total protein (g l –1 ) | 64 (23–86) | Unknown | Unknown |
| CRP (mg l –1 ) | 11 (<0.3–320) | Unknown | Unknown |
| Genotype | |||
| CYP3A4 | |||
| * 1 | 205 (86.5%) | 91 (91.0%) | 275 (90.5%) |
| * 22 | 22 (9.3%) | 9 (9.0%) | 29 (9.5%) |
| Unknown | 10 (4.2%) | 0 (0%) | 0 (0%) |
| CYP3A5 | |||
| * 1/ * 1 | 9 (3.8%) | 4 (4.0%) | 0 (0%) |
| * 1/ * 3 | 56 (23.6%) | 17 (17.0%) | 49 (16.1%) |
| * 3/ * 3 | 172 (72.6%) | 76 (76.0%) | 255 (83.9%) |
| * 3/ * 6 | 0 (0%) | 3 (3.0%) | 0 (0%) |
| ABCB1 3435C > T | |||
| CC | 55 (24.3%) | Unknown | Unknown |
| CT | 111 (49.1%) | Unknown | Unknown |
| TT | 60 (26.5%) | Unknown | Unknown |
| POR * 28 | |||
| CC | 128 (56.4%) | Unknown | Unknown |
| CT | 78 (34.4%) | Unknown | Unknown |
| TT | 21 (9.3%) | Unknown | Unknown |
| Primary diagnosis | |||
| Diabetic nephropathy | 48 (20.3%) | 21 (21.0%) | 16 (5%) |
| Polycystic kidney disease | 39 (16.5%) | 15 (15.0%) | 36 (12%) |
| Glomerulonephritis | 44 (18.6%) | 15 (15.0%) | 97 (32%) |
| Hypertensive nephropathy | 42 (17.7%) | 15 (15.0%) | 16 (5%) |
| Reflux/chronic pyelonephritis | 23 (9.7%) | 3 (3.0%) | 0 (0%) |
| Other | 20 (8.4%) | 26 (26.0%) | 51 (17%) |
| Unknown | 21 (8.9%) | 5 (5.0%) | 88 (29%) |
| Number of kidney transplantations | |||
| 1 | 218 (92.0%) | Unknown | 243 (80%) |
| 2 | 16 (6.8%) | Unknown | 49 (16%) |
| 3 or more | 3 (1.3%) | Unknown | 12 (4%) |
| RRT prior to transplantation | |||
| Haemodialysis | 90 (38.0%) | Unknown | Unknown |
| Peritoneal dialysis | 44 (18.6%) | Unknown | Unknown |
| Pre‐emptive | 102 (43.0%) | Unknown | Unknown |
| Delayed graft function | |||
| Yes | 11 (4.6%) | Unknown | Unknown |
| No | 224 (94.5%) | Unknown | Unknown |
| Unknown | 2 (0.8%) | Unknown | Unknown |
| Co‐medication | |||
| Calcium channel blockers | Unknown | Unknown | |
| Amlodipine | 25 (10.5%) | ||
| Nifedipine | 44 (18.6%) | ||
| Barnidipine | 2 (0.8%) | ||
| Time of tacrolimus concentration measurement (days after transplantation) | 23.7 (0.7–99.9) | 7.2 (3–100) | 30 (6–97.5) |
| Distribution of tacrolimus samples | |||
| Total samples | 3661 | 866 | 1334 |
| 0–7 days post‐transplantation | 734 (20.0%) | 359 (41.5%) | 287 (21.5%) |
| 8–14 days post‐transplantation | 642 (17.5%) | 244 (28.2%) | 60 (4.5%) |
| 15–30 days post‐transplantation | 722 (19.7%) | 113 (13.0%) | 604 (45.3%) |
| 31–100 days post‐transplantation | 1563 (42.7%) | 150 (17.3%) | 383 (28.7%) |
Model building group 1 consists of patients transplanted in the Erasmus MC (Rotterdam cohort). Model building group 2 consists of patients transplanted in the LUMC (Leiden cohort)
ASAT, aspartate aminotransferase; CRP, C‐reactive protein; CYP, cytochrome P450; POR*28, P‐450 oxidoreductase*28; RRT, renal replacement therapy
*
Presented as median and range over a 3‐month period for continuous variables