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

Sponsor
Karolinska University Hospital
Study ID
NCT07779187
Status
Not Yet Recruiting

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Conditions

  • DCD Kidney
  • Kidney Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Aug 21, 2026
Start date
Jan 1, 2027
Status verified
Aug 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
214 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NRP + HMPO2
    DCD kidneys recovered with NRP and undergoing ex situ HMPO2 initiated at donor hospital as the intervention
  • No Intervention: NRP alone
    DCD kidneys recovered with NRP followed by static cold storage

Primary Outcome Measure

Renal function after transplantation [ Time Frame: One year after transplantation ]

Central Contacts

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