Secondary outcome measures
thrombosis, DGF, necrosis
THROMBOSIS, NECROSIS
Nine participants had PNF (three in the SCS arm and six in the NMP arm) and were excluded from subsequent analyses. In the SCS arm, two patients had a vascular thrombosis, and one had cortical necrosis. In the NMP arm, one patient had a vascular thrombosis; two patients had acute rejection; and, in three cases, the reason was unknown. No significant difference was observed in the number of patients who experienced PNF between the treatment arms for both the MITT analysis (adjusted OR (95% CI) 2.34 (0.56–9.86); Table Patients who experienced DGF were excluded from the outcomes and analyses for functional DGF, creatinine reduction ratio on post-transplant day 2 (CRR2) and creatinine reduction ratio on post-transplant day 5 (CRR5). The median duration of DGF was 6 (2–9) days in the SCS arm and 4 (1–9) days in the NMP arm. No significant difference was observed between the groups in the MITT (adjusted hazard ratio (HR) (95% CI) 0.97 (0.70–1.34); Table The total number of patients who had biopsy-proven acute rejection was 19 in the SCS group and 24 in the NMP group. The unadjusted mean number of biopsy-proven acute rejection episodes per patient was numerically higher in the NMP arm compared to the SCS arm (0.3 per participant versus 0.2, respectively) but was not statistically different (adjusted rate ratio (95% CI) 1.57 (0.83–2.95) for the MITT population; Table Serum creatinine and estimated glomerular filtration rate (eGFR) were not statistically significant at 1, 3, 6 or 12 months after transplant in the MITT or per-protocol analyses (