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. 2023 May 25;34(8):1456–1469. doi: 10.1681/ASN.0000000000000160

Table 2.

Primary outcomes

Using Banff 2015 Classification Intervention Arm Control Arm RR (95% CI); P Value
Intention-to-treat analysis (n=241) n=120 n=121
 Combined end point 61 (51%) 59 (49%) 1.04 (0.81 to 1.34); 0.80
    Death-censored graft loss within first year 1 (1%) 3 (2%) 0.34 (0.04 to 3.19); 0.62
    Clinical rejection day 30–1 yr 16 (13%) 17 (14%) 0.95 (0.50 to 1.79); 1.00
    Acute rejection in 1-yr surveillance biopsy (n=201) 46 (45%) 38 (38%) 1.17 (0.85 to 1.63); 0.39
    Chronic active TCMR in 1-yr surveillance biopsy (n=201) 6 (6%) 8 (8%) 0.73 (0.26 to 2.02); 0.59
    De novo HLA-DSA at 1 yr (n=232) 6 (5%) 4 (3%) 1.50 (0.43 to 5.18); 0.75
    eGFR <25 ml/min at 1 yr (n=232) 1 (1%) 4 (3%) 0.25 (0.03 to 2.20); 0.37
Modified intention-to-treat analysis (n=201) n=102 n=99
 Combined end point 58 (57%) 50 (51%) 1.13 (0.87 to 1.46); 0.40
    Clinical rejection day 30–1 yr 13 (13%) 12 (12%) 1.05 (0.50 to 2.19); 1.00
    Acute rejection in 1-yr surveillance biopsy 46 (45%) 38 (38%) 1.17 (0.85 to 1.63); 0.39
    Chronic active TCMR in 1-yr surveillance biopsy 6 (6%) 8 (8%) 0.73 (0.26 to 2.02); 0.59
    De novo HLA-DSA at 1 yr 6 (6%) 3 (3%) 1.94 (0.50 to 7.55); 0.50
    eGFR<25 ml/min at 1 yr 1 (1%) 2 (2%) 0.49 (0.04 to 5.27); 0.62
Per-protocol analysis (n=175) n=82 n=93
 Combined end point 45 (55%) 46 (49%) 1.11 (0.84 to 1.47); 0.54
    Clinical rejection day 30 to 1 yr 10 (12%) 10 (11%) 1.13 (0.50 to 2.59); 0.81
    Acute rejection in 1-yr surveillance biopsy 37 (45%) 35 (38%) 1.20 (0.84 to 1.71); 0.36
    Chronic active TCMR in 1-yr surveillance biopsy 4 (5%) 8 (9%) 0.57 (0.18 to 1.81); 0.38
    De novo HLA-DSA at 1 yr 5 (6%) 3 (3%) 1.89 (0.47 to 7.67); 0.48
    eGFR <25 ml/min at 1 yr 1 (1%) 1 (1%) 1.13 (0.07 to 17.85); 1.00
Using Banff 2019 Classification
Intention-to-treat analysis (n=241) n=120 n=121
 Combined end point 27 (23%) 29 (24%) 0.94 (0.59 to 1.49); 0.88
    Clinical rejection day 30–1 yr 8 (7%) 9 (7%) 0.89 (0.36 to 2.25); 1.00
    Acute rejection in 1-yr surveillance biopsy (n=201) 11 (11%) 9 (9%) 1.19 (0.51 to 2.74); 0.81
Modified intention-to-treat analysis (n=201) n=102 n=99
 Combined end point 25 (25%) 21 (21%) 1.16 (0.69 to 1.92); 0.62
    Clinical rejection day 30–1 yr 6 (6%) 5 (5%) 1.16 (0.37 to 3.69); 1.00
    Acute rejection in 1-yr surveillance biopsy 11 (11%) 9 (9%) 1.19 (0.51 to 2.73); 0.81
Per-protocol analysis (n=175) n=82 n=93
 Combined end point 19 (23%) 20 (22%) 1.08 (0.62 to 1.87); 0.86
    Clinical rejection day 30–1 yr 5 (6%) 5 (5%) 1.13 (0.34 to 3.78); 1.00
    Acute rejection in 1-yr surveillance biopsy 8 (10%) 9 (10%) 1.01 (0.41 to 2.49); 1.00

Data are given as count (percentage). P-values are calculated by two-tailed Fisher exact test. CI, confidence interval; TCMR, T-cell–mediated rejection; HLA-DSA, donor-specific HLA antibodies.