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<p>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. NKP1 is 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. 30-day graft survival (primary endpoint) was 100%. Secondary objectives were assessment of the effect of NMP on post-transplant clinical outcomes and ischaemia-reperfusion injury, identification of predictive biomarkers, and characterisation of the performance of the preservation system. Clinical outcomes were comparable to a matched control cohort with 12-month estimated glomerular filtration rate (eGFR) 46.3 vs 49.5 mL/min/1.73m<sup>2</sup> (p = 0.44) despite much longer total preservation times (15.7 vs 8.9 hours controls, p &lt; 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, <i>R</i> = 0.54, <i>p</i> = 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.</p>

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Prolonged normothermic perfusion of the kidney prior to transplantation: a historically controlled, phase 1 cohort study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月17日

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  • Richard Dumbill,
  • Simon Knight,
  • James Hunter,
  • John Fallon,
  • Daniel Voyce,
  • Jacob Barrett,
  • Matt Ellen,
  • Elizabeth Conroy,
  • Ian SD Roberts,
  • Tim James,
  • Gabrielle Allen,
  • Jennifer Brook,
  • Annemarie Weissenbacher,
  • Rutger Ploeg,
  • Constantin Coussios,
  • Peter Friend

摘要

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. NKP1 is 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. 30-day graft survival (primary endpoint) was 100%. Secondary objectives were assessment of the effect of NMP on post-transplant clinical outcomes and ischaemia-reperfusion injury, identification of predictive biomarkers, and characterisation of the performance of the preservation system. Clinical outcomes were comparable to a matched control cohort with 12-month estimated glomerular filtration rate (eGFR) 46.3 vs 49.5 mL/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.