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. Author manuscript; available in PMC: 2017 Sep 3.
Published in final edited form as: Lancet. 2016 Jul 22;388(10048):983–993. doi: 10.1016/S0140-6736(16)30826-1

Table 1.

Demographic and clinical characteristics of comparison groups

All patients vs patients with biopsy at
12 months
High vs low CADI-12 scores Progression of CADI scores vs wno
progression



Patients
included in
microarray
analysis
(n=159)
Patients with
biopsy at
12 months
(n=101)
p
value
Patients with
high CADI-12
scores (n=44)
Patients with
low CADI-12
scores (n=57)
p value Progression by
12 months
(n=14)
No
progression
by 12 months
(n=52)
p
value
Donor age (years) 41·13 (16·80) 40·73 (16·80) 0·87 45·45 (18·05) 37·07 (14·91) 0·0121 46·50 (18·85) 37·69 (17·51) 0·1

Donor sex female 77 (48%) 46 (46%) 0·7 23 (52%) 28 (49%) 0·84 6 (43%) 28 (54) 0·76

Donor race 0·64 1 0·72
    Caucasian 121 (76%) 80 (79%) 35 (80%) 46 (81%) 11 (79%) 43 (83%)
    African American 17 (11%) 8 (8%) 4 (9%) 3 (5%) 3 (21%) 2 (4%)
    Hispanic 12 (8%) 5 (5%) 1 (2%) 4 (7%) 0 3 (6%)
    Other/unreported 9 (6%) 8 (8%) 4 (9%) 4 (7%) 0 4 (8%)

Donor vital status 0·79 0·31 0·23
    Deceased 94 (59%) 58 (57%) 28 (63%) 30 (53%) 10 (71%) 28 (54%)
    Alive 65 (41%) 43 (43%) 16 (7%) 27 (43%) 4 (29%) 4 (8%)

Recipient age (years) 48·84 (13·27) 46·90 (12·38) 0·24 49·86 (11·23) 44·43 (12·80) 0·0281 49·92 (8·69) 46·90 (12·29) 0·39

Recipient sex female 45 (28%) 32 (32%) 0·57 17 (39%) 15 (26%) 0·18 6 (43%) 17 (33%) 0·53

Recipient race 0·33 0·45 0·48
    White 92 (58%) 66 (65%) 26 (59%) 40 (70%) 8 (57%) 17 (73%)
    African American 37 (23%) 15 (15%) 7 (16%) 8 (14%) 3 (21%) 6 (12%)
    Hispanic 14 (9%) 7 (7%) 4 (9%) 3 (5%) 0 (0%) 2 (4%)
    Other/unreported 16 (10%) 13 (13%) 7 (16%) 6 (11%) 3 (21%) 6 (12%)

Recipient end stage renal
disease diagnosis
0·52 0·84 0·9
    Diabetic nephropathy 57 (36%) 33 (33%) 13 (30%) 20 (35%) 3 (21%) 17 (33%)
    Hypertension 24 (15%) 17 (17%) 7 (16%) 10 (18%) 3 (21%) 7 (13%)
    Glomerulonephritis 28 (18%) 22 (22%) 9 (20%) 13 (23%) 3 (21%) 12 (23%)
    Polycystic kidney 14 (9%) 13 (13%) 6 (14%) 7 (12%) 2 (14%) 7 (13%)
    Other 36 (23%) 16 (16%) 9 (20%) 7 (12%) 3 (21%) 9 (17%)

Previous renal transplant 4 (3%) 2 (2%) 1 1 (2%) 1 (2%) 1 1 (7%) 1 (2%) 0·38

eGFR at 3 months 59·18 (18·25) 59·48 (18·11) 0·9 53·23 (16·87) 64·36 (17·68) 0·0029 47·68 (15·59) 61·69 (17·33) 0·008

CADI score at 3 months
    Mean (SD) 1·78 (1·67) 1·74 (1·65) 0·89 2·45 (1·80) 1·20 (1·30) 0·0005 1·36 (1·28) 1·07 (1·06) 0·45
    Median (IQR) 1 (0–3) 1·5 (0–3) 2 (1–3) 1 (0–2) 1·5 (0–3) 1 (1–3)

Cold ischaemia time (h)* 14·64 (6·78) 13·81 (6·74) 0·46 13·99 (7·26) 12·64 (5·39) 0·45 13·62 (6·72) 13·78 (7·37) 0·95

Delayed graft function* 21 (13%) 9 (9%) 0·32 7 (25%) 2 (7%) 0·12 2 (20%) 4 (14%) 0·64

Anti-HLA antibodies 36 (23%) 26 (27%) 0·53 12 (29%) 14 (25%) 0·75 6 (17%) 9 (17%) 0·33

Donor-specific antibody
positive
7 (4%) 4 (4%) 3 (7%) 1 (2%) 2 (14%) 4 (8%)
    Class I 5 (3%) 3 (3%) 2 (5%) 1 (2%) 2 (14%) 4 (8%)
    Class II 3 (2%) 1 (1%) 0 (0%) 1 (2%) 1 (7%) 1 (2%)

Non-donor-specific
antibody positive
29 (20%) 22 (23%) 9 (21%) 13 (24%) 4 (29%) 5 (10%)
    Class I 29 (20%) 22 (23%) 9 (21%) 13 (24%) 4 (22%) 5 (10%)
    Class II 16 (11%) 9 (9%) 3 (7%) 6 (11%) 1 (7%) 3 (6%)

Induction therapy 0·67 0·5 0·75
    Thymoglobulin 49 (31%) 27 (27%) 13 (30%) 14 (25%) 4 (29%) 13 (25%)
    Anti-CD25 therapy 52 (33%) 39 (39%) 19 (43%) 20 (35%) 6 (43%) 23 (44%)
    Anti-CD52 therapy 9 (6%) 4 (4%) 2 (5%) 2 (4%) 0 1 (2%)
    None 49 (31%) 31 (31%) 10 (23%) 21 (37%) 4 (29%) 15 (29%)

12-month maintenance
immunosuppression
072 0·84 0·52
    Mycophenolate mofetil,
calcineurin inhibitors,
steroids
139 (87%) 90 (89%) 39 (89%) 51 (89%) 13 (93%) 50 (96%)
    Mycophenolate mofetil,
calcineurin inhibitors
12 (8%) 8 (8%) 2 (5%) 6 (11%) 1 (7%) 1 (2%)
    Others 8 (5%) 3 (3%) 3 (7%) 0 0 1 (2%)

Acute rejection within
1 year
22 (14%) 22 (22%) NA 17 (39%) 5 (9%) 0·0005 5 (36%) 6 (12%) 0·36

Data are mean (%) or mean (SD) unless noted otherwise. p values are calculated with the Mann-Whitney test (for non-parametric comparisons) or unpaired t test for continuous variables and χ2 or Fisher’s exact test for categorical data. CADI-12 scores of 2 or more were deemed to be high and scores of less than 2 were deemed to be low. Progression was shown by a CADI-3 score of 3 or less and an increase of CADI score of at least 2 points. Delayed graft function was defined as need for dialysis within the first 7 days after transplantation. CADI-12=chronic allograft damage index at 12 months. eGFR=estimated glomerular filtration rate. HLA=human leucocyte antigen.

*

Deceased donors only.

Only 148 of 159 patients included in microarray analysis and 97 of 101 patients with biopsies at 12 months had baseline anti-HLA antibodies reported in the database: 42 patients with high CADI and 55 with low CADI had anti HLA antibodies reported; all 14 progressors and 52 non-progressors had anti-HLA antibodies reported.