Table 2A.
Patient demographics. All cohorts.
| Group | Number patients | Age at transplantation | Gender Female (%) | Donor type living (%) | Time to biopsy (days) |
|---|---|---|---|---|---|
| Total patients used from KALIBRE study | |||||
| KTRs (all) | 248 | 47 (17–73) | 92 (37) | 138 (56) | – |
| Rejectors (all) | 66 | 48 (18–71) | 25 (38) | 38 (58) | 68 (4–384) |
| Signature development patients (KALIBRE study) | |||||
| Rejectors (TCMR) | 27 | 39 (19–68) | 9 (33) | 16 (59) | 103 (5–364) |
| Stable (Discovery)* | 27 | 41 (19–70) | 9 (33) | 17 (63) | – |
| BKVN* | 7 | 54 (36–69) | 1 (14) | 4 (57) | 195 (51–369) |
| Cross-sectional validation patients (KALIBRE study) | |||||
| Category 1 | 8 | 42 (24–64) | 2 (25) | 4 (50) | 87 (25–189) |
| Category 3 | 33 | 49 (25–73) | 14 (42) | 10 (30) | 49 (7–196) |
| Category 5 | 10 | 53 (33–70) | 4 (40) | 5 (50) | 58 (7–185) |
| Category 6 | 38 | 54 (18–71) | 14 (37) | 15 (39) | 56 (6–336) |
| Rejectors (Mixed-type) | 9 | 52 (24–64) | 4 (44) | 2 (22) | 87 (5–349) |
| Stable (Validation)⁎ | 17 | 43 (25–68) | 5 (29) | 10 (59) | – |
| Rejectors (pre-transplantation) | 18 | 38 (18–64) | 5 (28) | 16 (89) | 99 (4–384) |
| Stable (pre-transplantation) | 20 | 41 (19–70) | 8 (40) | 16 (80) | – |
| Rejectors (Rituximab/Alemtuzumab) | 10 | 42 (30–69) | 3 (30) | 10 (100) | 21 (4–367) |
| Longitudinal validation patients (KALIBRE study) | |||||
| Rejectors (TCMR + Mixed) | 51 | 48 (18–71) | 20 (39) | 26 (51) | 78 (4–384) |
| Stable (Discovery + Validation) | 44 | 42 (19–70) | 14 (32) | 27 (61) | – |
| Non-rejectors (Basiliximab) | 35 | 46 (18–73) | 14 (40) | 24 (69) | – |
| Non-rejectors (Alemtuzumab) | 9 | 43 (36–65) | 4 (44) | 8 (89) | – |
| Non-rejectors (Rituximab) | 18 | 47 (17–72) | 8 (44) | 18 (100) | – |
| External validation patients (EMPIRIKAL trial) | |||||
| Rejectors (TCMR + Mixed) | 9 | 57 (23–79) | 4 (44) | 0 | 8 (7–69) |
| Non-rejectors (External) | 15 | 50 (20–76) | 4 (27) | 0 | – |
| Healthy controls (GAMBIT study) | |||||
| Healthy Controls | 14 | 45 (23–72) | 3 (21) | – | – |
Patients contributed all individual samples for longitudinal validation, while for cross-sectional comparisons and signature development contributed a summary sample with median values per patient; Age at transplantation and Time to biopsy – summarised with median (minimum – maximum) per group; Longitudinal samples – covered the period between days four and 400 post transplantation; Rejector – a patient with a biopsy-proven rejection; TCMR – T-cell-mediated rejection; Mixed – histological features of TCMR and antibody-mediated rejection; Stable - patients fulfilling the inclusion/exclusion criteria in Table 1; Non-rejector – patients not fulfilling the selection criteria in Table 1 but without clinical or histological evidence of TCMR, ABMR or BKVN up to day 400 post-transplantation; BKVN – patients with biopsy-proven BK-virus nephropathy fulfilling the criteria in Table 1; Biopsy categories – non-rejection features, according to Banff’09 classification (category 1 – normal, category 3 – borderline changes, category 5 - interstitial fibrosis and tubular atrophy, category 6 – other non-rejection histology).