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Not Yet Recruiting NCT07779187

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

Conditions: Kidney Transplant, DCD Kidney

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 214
Sponsor: Karolinska University Hospital

Location: Sahlgrenska University Hospital Gothenburg

Summary

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

Inclusion Criteria: Donor kidneys: 1. All DCD donors in Sweden with consent for organ donation and where organ recovery is undertaken with NRP. 2. Kidney deemed transplantable by donor surgeon and responsible transplant surgeon (not discarded before or during procurement) Recipients: 1. All adult patients (\>18 yrs old) eligible for renal transplantation during study duration. 2. Recipient consented for surgery, matched to a DCD kidney. Exclusion Criteria: Donor kidneys: 1\. Kidney allocated outside of Sweden according to Scandiatransplant allocation rules. Recipients: 1. Paediatric patients (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07779187). StuddyBuddy aggregates publicly available trial information.