Actively Recruiting
Deceased Donor Kidney Storage at 10 Celsius Versus Conventional Storage
Led by Vanderbilt University Medical Center · Updated on 2026-04-06
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
T
Traferox Technology Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates how the storage temperature of deceased donor kidneys affects kidney function after transplant in adult patients. It aims to compare kidney transplants stored at 10°C versus the conventional storage on ice at 4°C to determine if storage at 10°C leads to better post-transplant kidney function. The study addresses delayed graft function, a common complication after kidney transplant, caused by ischemic reperfusion injury during organ storage. The trial involves two groups: one receiving kidneys stored at 10°C using the Traferox XPort device that maintains this temperature during storage and transport, and the other receiving kidneys stored conventionally on ice. Kidneys stored at 10°C come from participating organ procurement organizations, while others are stored on ice. Transplants proceed following usual clinical practice, with identical immunosuppression protocols for both groups. Participants will have urine collected 24 hours after surgery for research analysis, including measurement of urine NGAL as the primary outcome. Routine clinical information, such as delayed graft function within 7 days and kidney function trends over one month, will also be monitored. Data will be gathered from medical records, and participant involvement continues through the transplant and immediate post-operative period.
CONDITIONS
Brief Title
Deceased Donor Kidney Storage at 10 Celsius Versus Conventional Storage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult single organ kidney transplant candidates on the waiting list at Vanderbilt University Medical Center
- Donation after brain death or donation after circulatory death kidney donors with consent for donation and research
- Deceased donor kidneys allocated to Vanderbilt University Medical Center as a primary match offer before organ procurement
You will not qualify if you...
- Kidney transplant candidates younger than 18 years old
- Candidates who decline consent
- Candidates listed for multi-organ transplant
- Donors who declined consent for research
- Deceased donor kidneys allocated as backup or post procurement offers
- Deceased donor kidneys already placed on ice before transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From organ procurement until transplant
Deceased donor kidneys are stored using either a temperature-controlled device at 10˚C or on ice per routine clinical practice before transplant.
Duration - Transplant procedure and immediate recovery period
Participants undergo kidney transplant following routine clinical practice with kidneys stored at assigned temperature conditions.
Duration - Up to 1 month after transplant
Participants have urine collected 24 hours after transplant and routine clinical information is collected from medical records for analysis.
1 visit 24 hours post transplant and clinical data collected up to 1 month
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37027
Actively Recruiting
Research Team
W
W. Christian Crannell, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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