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

NCT07779187 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2026-08-21

No results posted yet for this study

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

Conditions

  • Kidney Transplant
  • DCD Kidney

Interventions

DEVICE

Ex situ hypothermic oxygenated machine preservation

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

Sponsors & Collaborators

  • Uppsala University Hospital

    collaborator OTHER

  • Skane University Hospital

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Karolinska University

    collaborator OTHER

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Gabriel C Oniscu, MD, PhD, FRCS · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07779187 on ClinicalTrials.gov