Table 2.
HLA Ab status.
| DSA+ |
Non-DSA+ |
No HLA Ab |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Blinded (SC) A1 |
Unblinded (BLC) B1 |
Blinded (SC) A2 |
Unblinded (BLC) B2 |
Blinded (SC) C |
Unblinded (BLC) D |
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| Time of Tx | Post-screening | End | Time of Tx | Post-screening | End | Time of Tx | Post-screening | End | Time of Tx | Post-screening | End | Time of Tx | Post-screening | End | Time of Tx | Post-screening | End | |
| Number of Ab+ (%) | 21 (22.8) | 92 (100) | 34 (37∗) | 23 (21.7) | 106 (100) | 38 (35.8) | 158 (40.4) | 389 (99.5) | 106 (27.1) | 153 (35.8) | 425 (99.5) | 99 (23.1) | 37 (7) | 2 (0.4) | 9 (1.7) | 33 (6.7) | 0 (0) | 8 (1.6) |
| Definite DSA | – | 91 (98.9) | 18 (19.6) | – | 103 (97.2) | 25 (23.6) | – | 0 (0) | 13 (3.3) | – | 0 (0) | 3 (0.7) | – | 0 (0) | 2 (0.4) | – | 0 (0) | 1 (0.2) |
| Definite non-DSA | – | 1a(1.1) | 13 (14.1) | – | 1a(0.9) | 10 (9.4) | – | 346 (88.5) | 86 (22) | – | 383 (89.7) | 92 (21.5) | – | 0 (0) | 7 (1.3) | – | 0 (0) | 5 (1) |
| Unknown whether DSA | – | 0 (0) | 3 (3.3) | – | 2a(1.8) | 3 (2.8) | – | 43 (11) | 7 (1.8) | – | 42 (9.8) | 4 (0.9) | – | 2b(0.6) | 0 (0) | – | 0 (0) | 2 (0.4) |
| Number of Ab – (%) | 64 (69.6) | 0 (0) | 35 (38) | 72 (67.9) | 0 (0) | 40 (37.7) | 192 (49.1) | 0 | 191 (48.8) | 230 (53.9) | 1c (0.2) | 210 (49.2) | 449 (85.4) | 521 (99) | 437 (83.1) | 431 (87.1) | 489 (98.8) | 402 (81.2) |
| Missing data | 7 (10.5) | 0 (0) | 23 (25) | 11 (10.4) | 0 (0) | 28 (26.4) | 41 (10.5) | 2 (0.5) | 94 (24) | 44 (10.3) | 1 (0.2) | 118 (27.6) | 40 (7.6) | 3 (0.6) | 80 (15.2) | 31 (6.3) | 6 (1.2) | 85 (17.2) |
| Total | 92 (100) | 92 (100) | 92 (100) | 106 (100) | 106 (100) | 106 (100) | 391 (100) | 391 (100) | 391 (100) | 427 (100) | 427 (100) | 427 (100) | 526 (100) | 526 (100) | 526 (100) | 495 (100) | 495 (100) | 495 (100) |
Patients grouped according to post-screening HLA Ab status; table shows details of their HLA Ab status at time of transplant and end of trial, and how their trial antibody status was classified. HLA Ab classified as ‘uncertain whether DSA’ were classified this way when not enough data on donor recipient mismatches was available: these HLA Ab were included in non-DSA groups for analysis.
[NB, during re-screening of HLA Ab-negative groups, upon becoming antibody positive, recruits not tested again until ‘end’ (= last trial visit)].
These patients were incorrectly identified as having DSA—refer to Supplementary File for details.
These patients developed Ab at the second round of screening (month 16) but were incorrectly maintained in the HLA Ab-negative group by mistake.
This patient was incorrectly randomised as having a non-DSA antibody.