Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07385651

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

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.

Treatment

Duration - Transplant procedure and immediate recovery period

Participants undergo kidney transplant following routine clinical practice with kidneys stored at assigned temperature conditions.

Post-operative Follow-up

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

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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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Frequently Asked Questions

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