*Purpose: Normothermic ex vivo kidney perfusion is a novel preservation technique with promising results in porcine models and initial clinical results in one European center. We report the first North American clinical safety and feasibility study with normothermic ex vivo perfusion (NEVKP) in human kidney transplantation.

*Methods: Thirteen human kidneys receiving cold anoxic perfusion, plus 1 to 3 hours of NEVKP prior to transplantation, were matched to 39 patients receiving continuous cold anoxic perfusion as preservation method. Perfusion characteristics during NEVKP, post-transplant graft function and 6-month graft survival were assessed.

*Results: NEVKP was performed for 149 minutes (44 to 275 min). During perfusion, renal artery flow improved from 326 to 464 ml/min (mean, p = 0.03) corresponding to a decrease of renal artery resistance from 0.27 to 0.18 (mean, p = 0.035). Similarly, the mean pH increased from 7.05 to 7.40 and the average urine output during NEVKP was 16 ml/hr (0 to 105 ml/hr). Glucose and lactate levels were stable during perfusion. After transplantation, kidneys with NEVKP vs. continuous cold anoxic perfusion had similar delayed graft function (31% vs 46%, p = 0.51), and comparable 6-month mean serum creatinine (107 vs 117 micromol/l, p = 0.84) and estimated glomerular filtration rate (55.3 vs 49.4 ml/min/1.73m², p = 0.96). Six-month graft survival was similar between the NEVKP and the cold stored group (92% vs 95%, p = 0.57).

*Conclusions: A short period of normothermic ex vivo kidney perfusion after cold storage is safe and feasible in clinical kidney transplantation. NEVKP was not superior to cold storage in this small pilot trial. Prolonged warm perfusion, with a reduction of cold storage, may be required to improve kidney transplant outcomes with NEVKP.

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