Trial patients
multi-organ, end-stage renal failure
END-STAGE RENAL FAILURE
Eligible patients enrolled on the transplant waiting list and allocated a suitably matched kidney were enrolled at four UK transplant centers. Inclusion criteria included recipients 18 years of age or older with end-stage renal failure requiring their first or second kidney transplant who received a kidney from Maastricht category III or IV DCD donors 18 years of age or older. Exclusion criteria included recipients receiving a third or subsequent kidney transplant, multi-organ transplants, dual kidney transplants, pediatric en bloc kidney transplants and kidneys preserved by HMP. Two additional exclusion criteria were introduced on 13 October 2017: donors who underwent normothermic regional perfusion or one of a pair already randomized as a single kidney in the trial. This was approved by the Research Ethics Service, local institutional review boards and the TSC. All patients provided written informed consent.Patients were randomly assigned in a 1:1 ratio to 1-h NMP or SCS. The randomization list was created by the trial statistician in SAS Enterprise Guide (version 5.1) with SAS 9.4, stratified by transplant center and using randomly permuted blocks of fixed size 2 and 4 for single and pairs of kidneys, respectively. In cases where paired kidneys from the same donor were transplanted in the same transplant center, the randomization was stratified by kidney (right or left) so that one kidney was randomly allocated to each treatment and in which order they should be transplanted. The randomization process was facilitated using an Interactive Web Response System. After the assignment of treatment arms, no one in the trial was blinded to the treatment allocation.