Table 1.
Baseline characteristics.
| Variables | Total (n = 20) | Clazakizumab (n = 10) | Placebo (n = 10) |
|---|---|---|---|
| Variables recorded at transplantation | |||
| Female sex, n (%) | 10 (50) | 3 (30) | 7 (70) |
| Recipient age (years), median (IQR) | 34.2 (24.6–47.6) | 37.4 (27.1–57.9) | 31.4 (22.3–42.3) |
| Deceased donor, n (%) | 14 (70) | 7 (70) | 7 (70) |
| Living donor, n (%) | 6 (30) | 3 (30) | 3 (30) |
| Prior kidney transplant, n (%) | 7 (35) | 4 (40) | 3 (30) |
| Current CDC panel reactivity ≥10%, n (%)* | 6 (33.3) | 3 (33.3) | 3 (33.3) |
| Preformed anti‐HLA DSA, n (%)† | 5 (45.5) | 3 (42.9) | 2 (50) |
| Donor age (years), median (IQR)‡ | 49.0 (21.8–57.3) | 51.0 (21.8–57.3) | 44.0 (23.3–66.0) |
| HLA mismatch (A, B, DR), median (IQR)§ | 3 (2–3) | 3 (3–3) | 3 (2–3) |
| Variables recorded at trial inclusion | |||
| Age of study patients (yr), median (IQR) | 41.5 (36.4–60.1) | 47.2 (38.7–62.1) | 39.6 (30.2–59.6) |
| Year to inclusion in the trial | 10.6 (4.4–16.2) | 9.7 (4.1–16.7) | 11.4 (5.9–16.1) |
| eGFR (ml/min per 1.73 m2 ), median (IQR) | 39.3 (33.6–49.7) | 40.5 (33.3–49.8) | 39.2 (32.9–51.7) |
| Protein/creatinine ratio (mg/g), median (IQR) | 962 (310–1,863) | 727 (197–1,311) | 1,387 (532–3,575) |
| ABMR phenotype (Banff 2017) | |||
| Active ABMR, n (%) | 2 (10) | 2 (20) | 0 |
| Chronic/active ABMR, n (%) | 18 (90) | 8 (80) | 10 (100) |
ABMR, antibody‐mediated rejection; DSA, donor‐specific antibody; CDC, complement‐dependent cytotoxicity; eGFR, estimated glomerular filtration rate; IQR, interquartile range.
*
CDC panel reactivity was not recorded for 1 recipient in the clazakizumab arm and 1 in the placebo arm.
†
Pretransplant DSA data were available for 7 recipients in the clazakizumab arm and 4 in the placebo arm (solid‐phase HLA antibody screening on the wait list was implemented at the Vienna transplant unit in July 2009).
‡
Donor age was not recorded for 2 recipients in the placebo arm.
§
HLA mismatch was not recorded for 1 recipient in the placebo arm.