NKP1

• Research type

  Research Study

• Full title

  Normothermic Kidney Perfusion Phase 1

• IRAS ID

  271359

• Contact name

  Peter Friend

• Contact email

  peter.friend@nds.ox.ac.uk

• Sponsor organisation

  University of Oxford / Clinical Trials and Research Governance

• ISRCTN Number

  ISRCTN13292277

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  This study aims to demonstrate the safety and feasibility of using a novel device for preserving kidneys prior to transplantation. The current standard of care is for kidneys to be transported from the donor hospital to the recipient on ice (Static Cold Storage, SCS). Whilst cooling the organ slows the rate of metabolism and deterioration, it precludes assessment of the kidney in a functioning state and does not prevent deterioration.

  SCS affects kidneys from elderly donors and those with co-morbidities such as high blood pressure most severely, and these donors are accounting for an increasing number of transplants. The median waiting time for a kidney transplant in the UK is 829 days, with around 250 patients dying on the waiting list each year. An improved method of preservation would increase the proportion of available organs that could successfully be transplanted, decreasing waiting time and the number of deaths on the waiting list.

  We have developed a device that perfuses kidneys with oxygenated perfusate at normal body temperature (normothermic perfusion, NMP). We have demonstrated that kidneys that have been rejected for transplantation can be preserved in this manner for up to 24 hours. This study would bring this technology into clinical practice, starting with short duration perfusions of two hours and increasing up to 24 hours. Kidneys that are deemed suitable for transplantation will be transported to the Oxford Transplant Centre in the usual manner (SCS). Those that are appropriate for our study will be perfused for increasing lengths of time, then transplanted. We will assess the safety and feasibility of this technique, and simultaneously study the clinical outcomes and function of NMP-preserved kidneys; compare this to historical matched controls; examine the effects of NMP on the kidney; identify markers during preservation that may predict future kidney function; and characterise the perfusion system.

  Summary of Results
  We spoke to 405 patients about the trial in advance, and 92% told us that they would be interested in joining the trial. We spoke to 50 of these patients who were called in whilst the trial was running, and 48 wanted to go ahead. Of these 48, 36 patients ended up receiving a kidney that had been put on our machine. On average, kidneys spent just under 6 hours on our machine. The maximum time on the machine was just under 24 hours. One kidney was put on the machine then not transplanted because blood didn’t flow through it very well, which suggested that it would not work after the transplant.
  After transplantation, all 36 kidneys started working. There were no complications or issues post-transplant that were related to using the device. Unfortunately, one patient passed away during the 12-month follow-up period, and the kidney transplant failed in one other patient. There were no differences in any of the outcomes when we compared the results to similar transplants which we have done in the past, where the amount of time spent on ice was the same as in our trial. This included the proportion of patients who needed dialysis for a period of time after the transplant whilst waiting for the kidney to start working (known as delayed graft function), and kidney function blood tests done during the first year post-transplant.
  Whilst the kidneys were on the perfusion machine, we took samples of the blood used during perfusion that we could analyse later in the laboratory. We found that using these samples we could predict how well the kidney would work after the transplant. These results also suggest treatments that we might be able to give to kidneys whilst on the machine, to improve how well they work

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  20/NW/0442

• Date of REC Opinion

  3 Dec 2020

• REC opinion

  Further Information Favourable Opinion