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NOT YET RECRUITING
NCT07779187
NA

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

Sponsor: Karolinska University Hospital

View on ClinicalTrials.gov

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

Official title: Oxygenated Perfusion for Enhanced Renal Function in Donation After Circulatory Death (DCD) Kidney Transplants (OxyPERF) - A National Swedish Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

214

Start Date

2027-01-01

Completion Date

2030-12-31

Last Updated

2026-08-21

Healthy Volunteers

No

Interventions

DEVICE

Ex situ hypothermic oxygenated machine preservation

Ex situ preservation of NRP DCD kidneys with hypothermic oxygenated machine perfusion

Locations (3)

Sahlgrenska University Hospital

Gothenburg, Sweden

Skåne University Hospital

Malmö, Sweden

Akademiska Hospital

Uppsala, Sweden