Table 2 Pathology assessment of biopsies according to Banff criteria
No. events | % based on number of patients with ≥1 biopsy | % based on number of ITT patients | ||||||
|---|---|---|---|---|---|---|---|---|
Protocol-specified biopsies, n (%) | Everolimus | CsA | Everolimus | CsA | P valuea | |||
Biopsy at randomization | 22 | 18 | n = 22 | n = 18 | – | – | ||
BPAR grade 1A | 1 | 0 | 4.5 | 0 | 1.000 | – | ||
Borderline lesions | 4 | 3 | 18.2 | 16.7 | 1.000 | |||
Other | 1 | 1 | 4.5 | 5.6 | 1.000 | |||
Month 12 | 17 | 17 | n = 17 | n = 17 | – | |||
BPAR, any | 3 | 1 | 17.6 | 5.9 | 0.601 | – | ||
Grade 1A | 0 | 1 | ||||||
Grade 1B | 1 | 0 | ||||||
Grade 2A | 2 | 0 | ||||||
Chronic/sclerosing allograft nephropathy | ||||||||
Grade 1 | 1 | 1 | 5.9 | 5.9 | 1.000 | |||
CNI toxicity lesions | 1 | 0 | 5.9 | 0 | 1.000 | |||
Borderline lesions | 3 | 1 | 17.6 | 5.9 | 0.601 | |||
Investigator-initiated biopsy, n (%)b | Everolimus | CsA | Everolimus N = 61 | CsA N = 64 | P valuea | Everolimus N = 154 | CsA N = 146 | P valuea |
Before randomization | 61 | 64 | n = 61 | n = 64 | – | 39.6 | 43.8 | – |
BPAR, any | 11 | 17 | 18.0 | 26.6 | 0.288 | 7.1 | 11.6 | 0.234 |
Grade 1A | 9 | 7 | ||||||
Grade 1B | 0 | 2 | ||||||
Grade 2A | 1 | 0 | ||||||
Grade 2B | 0 | 2 | ||||||
Grade 3 | 0 | 0 | ||||||
Grade missing | 1 | 7 | ||||||
Antibody-mediated rejection | 2 | 2 | 3.3 | 3.1 | 1.000 | 1.3 | 1.4 | 1.000 |
Chronic/sclerosing allograft nephropathy | 2 | 2 | 3.3 | 3.1 | 1.000 | 1.3 | 1.4 | 1.000 |
Grade 1 | 1 | 1 | ||||||
Grade 2 | 1 | 1 | ||||||
Grade 3 | 0 | 0 | ||||||
CNI toxicity lesions | 17 | 20 | 27.9 | 31.3 | 0.700 | 11.0 | 13.7 | 0.489 |
Borderline lesions | 9 | 15 | 14.8 | 23.4 | 0.260 | 5.8 | 10.3 | 0.202 |
Acute tubular necrosis | 15 | 21 | 24.6 | 32.8 | 0.300 | 9.7 | 14.4 | 0.286 |
Chronic allograft glomerulopathy | 0 | 1 | 0 | 1.6 | 1.000 | 0 | 0.7 | 0.487 |
Donor lesions | 4 | 6 | 6.6 | 9.4 | 0.744 | 2.6 | 4.1 | 0.533 |
Other | 16 | 21 | 26.2 | 32.8 | 0.440 | 10.4 | 14.4 | 0.380 |
After randomization | 53 | 53 | n = 53 | n = 53 | – | 34.4 | 36.3 | – |
BPAR, any | 19 | 11 | 35.8 | 20.8 | 0.131 | 12.3 | 7.5 | 0.182 |
Grade 1A | 10 | 8 | ||||||
Grade 1B | 6 | 1 | ||||||
Grade 2A | 6 | 2 | ||||||
Grade 2B | 0 | 0 | ||||||
Grade 3 | 1 | 2 | ||||||
Grade missing | 1 | 0 | ||||||
Antibody-mediated rejection | 1 | 4 | 1.9 | 7.5 | 0.363 | 0.6 | 2.7 | 0.204 |
Chronic/sclerosing allograft nephropathy | 11 | 12 | 20.8 | 22.6 | 1.000 | 7.1 | 8.2 | 0.829 |
Grade 1 | 7 | 7 | ||||||
Grade 2 | 2 | 4 | ||||||
Grade 3 | 2 | 3 | ||||||
CNI toxicity lesions | 7 | 15 | 13.2 | 28.3 | 0.092 | 4.5 | 10.3 | 0.076 |
Borderline lesions | 14 | 11 | 26.4 | 20.8 | 1.000 | 9.1 | 7.5 | 0.680 |
Acute tubular necrosis | 2 | 1 | 3.8 | 1.9 | 1.000 | 1.3 | 0.7 | 1.000 |
Chronic allograft glomerulopathy | 7 | 4 | 13.2 | 7.5 | 0.526 | 4.5 | 2.7 | 0.543 |
Donor lesions | 0 | 2 | 0 | 3.8 | 0.495 | 0 | 1.4 | 0.236 |
Other | 27 | 14 | 50.9 | 26.4 | 0.016 | 17.5 | 9.6 | 0.063 |