Recruiting

Kidney vs. Kidney

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07385651

Conditions

End Stage Chronic Renal Failure

Chronic Kidney Disease (Stages 4 and 5)

Kidney Transplantation Recipients

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

10˚C deceased donor kidney storage using Traferox XPort

Study Details

Brief summary:

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

Conditions

End Stage Chronic Renal Failure

Chronic Kidney Disease (Stages 4 and 5)

Kidney Transplantation Recipients

Study ID

NCT07385651

Start date

Nov 18, 2024

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Participant inclusion criteria

1\. All adult single organ kidney transplant candidates on the waiting list at Vanderbilt University Medical Center (VUMC) will be eligible for enrollment.

Participant exclusion criteria

1. Kidney transplant candidates less than 18 years old
2. Kidney transplant candidates that decline consent
3. Transplant candidates listed for multi-organ transplant

Deceased donor organ inclusion criteria:

1. Donation after brain death or donation after circulatory death kidney donors, whose health care proxy has consented for donation and the possibility of research
2. Deceased donor kidneys that have been allocated to VUMC as a primary match offer prior to organ procurement will be eligible

Deceased donor organ exclusion criteria:

1. Donors whose health care proxy has declined consent for the possibility of research
2. Deceased donor kidneys that have been allocated to VUMC as a backup offer
3. Deceased donor kidneys that have been allocated to VUMC as a post procurement offer
4. Deceased donor kidneys that have already been placed on ice

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 10˚C deceased donor kidney storage

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.

no intervention: Conventional (ice storage) deceased donor kidney storage

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.

Interventions

10˚C deceased donor kidney storage using Traferox XPort

Deceased donor kidneys will be stored using the Traferox XPort device to maintain an organ temperature of 10˚C during storage and transport until the time of transplant

Primary outcome measure

  • Urine NGAL [ Time Frame: Urine collected post operatively day one after kidney transplant ]

Central Contacts and Locations

Central contacts

W. Christian Crannell, MD

615-322-5000christian.crannell@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37027

Contacts

W. Christian Crannell, MD

615-322-5000christian.crannell@vumc.org

Principal Investigator:

W. Christian Crannell, MD

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Apr 6, 2026

Last verified

Jan, 2026

Keywords

  • kidney transplant recipients
  • delayed graft function
  • ischemia reperfusion injury
  • 10 Celsius kidney storage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-04-06.