NRP + ex Situ HMPO2 vs NRP Alone in DCD Kidney Transplantation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska University Hospital

About this trial

The goal of this clinical trial is to learn if the combination of Normothermic Regional Perfusion (NRP) at the time of organ procurement with ex situ Hypothermic Oxygenated Perfusion (HMPO2) of kidneys recovered from donors after circulatory death (DCD) is superior to NRP alone. The researchers will learn if the combined use of these technologies provides a benefit in terms of kidney transplant outcomes. The researchers will also learn about the patient quality of life after these transplants and if the use of these technologies is cost efficient. The main questions it aims to answer are:

* Does NRP +HMPO2 provides a better DCD kidney function at 1 year post-transplant compared to NRP alone. * Are the postoperative complications and outcomes different between the two groups? * Is the quality of life of recipients different between the two groups? * Is the use of NRP +HMPO2 a cost effective strategy? Researchers will compare NRP and HMPO2 with NRP alone to see if the combined use of the technologies provides better transplant outcomes.

Participants will:

* Receive a kidney treated with one of the two strategies. * Visit the clinic as per usual clinical practice for checkups and tests * Report on their quality of life pre and post transplant * Undergo a kidney biopsy at one year to forecast long term transplant function

Eligibility criteria

Qualifiers

All DCD donors in Sweden with consent for organ donation and where organ recovery is undertaken with NRP.

Kidney deemed transplantable by donor surgeon and responsible transplant surgeon (not discarded before or during procurement)

All adult patients (>18 yrs old) eligible for renal transplantation during study duration.

Recipient consented for surgery, matched to a DCD kidney.

Disqualifiers

Paediatric patients (<18 yrs old).

Participation in other clinical drug or medical devices trials.

Patient subject to combined transplant of kidney + other organ.

Trial design

Treatments tested in this trial

  • Ex situ hypothermic oxygenated machine preservation

Treatment groups

214 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Karolinska University Hospital

Lead sponsor

Uppsala University Hospital

Collaborator

Skane University Hospital

Collaborator

Sahlgrenska University Hospital

Collaborator

Karolinska University

Collaborator