Prolonged normothermic perfusion of the kidney – a historically controlled, phase 1 cohort study

Abstract

Kidney transplantation is the preferred treatment for end-stage renal disease and is limited by donor organ availability. Normothermic Machine Perfusion (NMP) might facilitate safe transplantation of marginal organs. Previous clinical implementations have been limited to short perfusions. NKP1 was a single centre, phase 1, 36-patient, three-stage cohort study investigating the safety and feasibility of up to 24 hours of renal NMP prior to transplantation. We observed a 30-day graft survival of 100%, with comparable outcomes to a matched control cohort (12-month estimated glomerular filtration rate (eGFR) 46.3 vs 49.5mL/min/1.73m², p=0.44) despite much longer total preservation times (15.7 vs 8.9 hours controls, p <0.0001). We saw strong correlations between biomarkers measured ex-situ and post-transplant outcomes, including graft function at one year (correlation between GST-Pi delta and 12-month eGFR, R=0.54, p=0.001). Renal NMP is useful for optimising logistics and as an organ assessment technique, and has potential to expand the donor pool. Trial registration number: ISRCTN13292277.