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

Study acronym: OxyPerf
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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
Trial Details
NCT Number NCT07779187
Lead Sponsor Karolinska University Hospital
Collaborators: Uppsala University Hospital, Skane University Hospital, Sahlgrenska University Hospital, Karolinska University
Conditions
(from sponsor)
Kidney Transplant, DCD Kidney
Enrollment 214 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov