Deceased Donor Kidney Storage at 10 Celsius Versus Conventional Storage

NCT07385651 | Active Not Recruiting FDA Device

• 1 other identifier: 241113
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Urine NGAL

  Neutrophil gelatinase-associated lipocalin (NGAL), a urine biomarker for acute kidney injury that has been shown to be predictive of delayed kidney graft function. Urine will be collected after the kidney transplant, processed and stored with an anonymous ID.

  Urine collected post operatively day one after kidney transplant

Secondary Outcomes (3)

• Delayed graft function

  Within 7 days after kidney transplant

• Post operative urine output

  24 hours after kidney transplant

• Creatinine and estimated glomerular filtration rate trends

  One month post operatively after kidney transplant

Study Arms (2)

10˚C deceased donor kidney storage

EXPERIMENTAL

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.

Device: 10˚C deceased donor kidney storage using Traferox XPort

Conventional (ice storage) deceased donor kidney storage

NO INTERVENTION

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 DEVICE

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

10˚C deceased donor kidney storage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Kidney transplant candidates less than 18 years old
• Kidney transplant candidates that decline consent
• Transplant candidates listed for multi-organ transplant
• Donation after brain death or donation after circulatory death kidney donors, whose health care proxy has consented for donation and the possibility of research
• Deceased donor kidneys that have been allocated to VUMC as a primary match offer prior to organ procurement will be eligible
• Donors whose health care proxy has declined consent for the possibility of research
• Deceased donor kidneys that have been allocated to VUMC as a backup offer
• Deceased donor kidneys that have been allocated to VUMC as a post procurement offer
• Deceased donor kidneys that have already been placed on ice

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Traferox Technology Inc.: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37027, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Delayed Graft Function; Reperfusion Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications

Study Officials

• W. Christian Crannell, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: If the donor kidney is coming from an organ procurement organization(s) (OPO) participating in the trial, the study organ coordinator will alert the on-site procurement team that the kidney is to be placed at 10˚C (the intervention arm). If the donor kidney is outside of a participating OPO these organs are automatically stored on ice (the control arm)

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 4, 2026
• Study Start: November 18, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: January 2026 through January 2028
• Access Criteria: Other researchers will be able to email the primary investigator to request: de-identified participant data, results, and other study materials including the protocol and blank informed consent documents. No identifiable participant data will be released.

Locations

US (1)