Kidney Storage Temperature for Transplant Recipients
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to test how storage temperature of deceased donor kidneys affects kidney function after transplant in adult patients receiving a kidney transplant.
The main question it aims to answer is:
• Do patients that receive a kidney transplant stored at 10 °C have improved post-transplant kidney function? Researchers will compare patients who receive kidneys stored at 10 °C versus kidneys stored at 4°C (on ice, i.e. conventional storage) to see if kidneys stored at 10 °C have improved function.
Participants will:
* Be made aware of and consent to receive a kidney transplant that had been stored at 10 °C
* Have their urine collected 24 hours after surgery to be analyzed for research
Who Is on the Research Team?
W. Christian Crannell, MD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
This trial is for adult kidney transplant candidates at Vanderbilt University Medical Center. It's focused on those who are willing to receive a kidney stored at a warmer temperature (10°C) and agree to have their urine collected after surgery for research.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a kidney transplant with the organ stored at either 10°C or on ice
Post-operative Monitoring
Participants' urine is collected and analyzed 24 hours after surgery
Follow-up
Participants are monitored for delayed graft function and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Traferox XPort
Trial Overview
Researchers are testing if kidneys stored at 10°C before transplant work better than the usual method of storing them on ice (4°C). Participants will be compared based on how well their new kidney functions after the operation.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Deceased donor kidneys from participating organ procurement organizations (OPO) will be procured per OPO routine clinical practice and then stored at 10˚C in dedicated temperature controlled coolers until transplant at Vanderbilt University Medical Center. Donor kidneys will be labeled with the anonymous United Network for Organ Sharing number. The transplant will then proceed per routine clinical practice and usual clinical pathways will be followed. Post operatively, study participants will have their urine collected 24 hours post operatively and analyzed. Routine clinical information will be abstracted from the electronic medical record and used for analysis.
Deceased donor kidneys, not meeting eligibility for the intervention arm, that are accepted for transplant at Vanderbilt University Medical Center will be procured per routine clinical practice and stored conventionally on ice. Donor kidneys will be labeled with the anonymous United Network for Organ Sharing number. The transplant will proceed per routine clinical practice. Usual clinical pathways will be followed. Post operatively, study participants will have their urine collected 24 hours post operatively and analyzed. Routine clinical information will be abstracted from the electronic medical record and used for analysis.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Traferox Technology Inc.
Collaborator
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