NCT01170910

Methods	Multicenter, prospective, open, controlled and randomised trial comparing static incubation and pulsatile machine perfusion in expanded criteria donors
Participants	Inclusion criteria for donors (ECD) Donors aged > 60 years Donors aged between 50 and 60 years of age with at least one of the following characteristics: history of diabetes mellitus; history of high blood pressure; SCr > 1.5 mg/dL; death by stroke (haemorrhagic or thrombotic) Inclusion criteria for recipient Registered on the kidney transplant waiting list likely to receive a marginal kidney Immunized patients whose anti‐HLA antibody specificities have been determined Exclusion criteria for recipient Pregnant or breastfeeding women People who have been incarcerated Minors Adults under guardianship People who are not affiliated with the French healthcare system People with HLA immunization whose HLA antibody specificities have not been determined
Interventions	Static incubation Kidneys in this group are conserved in University of Wisconsin (e.g., UW, Belzer® or Viaspan®), IGL‐1, or SCOT solution before being transplanted Pulsatile perfusion Kidneys in this group are placed in the pulsatile perfusion machine (RM 3) within two hours and should be kept there at least 6 hours and 8 hours if possible, before being transplanted
Outcomes	DGF Evaluate improvement in the glomerular filtering rate: 12 months after transplantation Evaluate the recourse to dialysis: 3 months following transplantation Evaluate the proportion of functional grafts (which allows for renal purification without recourse to dialysis): 12 months after transplantation Evaluate patient survival: 12 months after transplantation Stratify the analysis of regaining function and graft survival using Nyberg's classification in order to determine which risk groups would most benefit from pulsatile perfusion: 12 months after transplantation Identify perfusion profiles of the machine, which predict regaining kidney function (absence of dialysis during the week after transplantation) and graft survival: 12 months after transplantation Evaluate the medico‐economic impact of each conservation strategy in the management of patients who will benefit from marginal grafts: 12 months after transplantation
Notes	Study marked as complete (www.clinicaltrials.gov/ct2/show/study/NCT01170910) but no results available despite attempted contact with the authors.

DGF ‐ delayed graft function; ECD ‐ extended/expanded criteria donors; SCr ‐ serum creatinine