Kidney Storage Temperature for Transplant Recipients

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the storage temperature of kidneys from deceased donors affects their function after a transplant. It compares kidneys stored at 10°C to those stored traditionally on ice at 4°C. The goal is to determine if the warmer temperature improves kidney function post-surgery. Adults on the kidney transplant waiting list at Vanderbilt University Medical Center are suitable candidates for this study. Participants must agree to receive a kidney stored at the higher temperature using the Traferox XPort system. As an unphased trial, this study allows patients to contribute to innovative research that could enhance kidney transplant outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this kidney storage method is safe for transplant recipients?

Research has shown that storing organs like lungs at 10°C for up to 24 hours is as safe as the usual method of storing them at 4°C for 6 hours. This finding suggests that keeping donor kidneys at 10°C might also be safe. The Traferox XPort system, used for organ storage, has manageable side effects for patients with kidney transplant issues. Although specific data on storing kidneys at 10°C is lacking, evidence from other organs suggests it could be well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to store kidneys before transplant. Unlike the standard method of storing kidneys on ice, which can sometimes damage the organ due to freezing temperatures, this trial investigates storing kidneys at a controlled temperature of 10˚C. The hope is that this method could better preserve kidney function and improve transplant outcomes. By finding the optimal storage temperature, researchers aim to enhance the quality and longevity of transplanted kidneys, potentially benefitting many transplant recipients in the future.

What evidence suggests that storing kidneys at 10°C is effective for improving post-transplant kidney function?

Research has shown that storing organs at 10°C can improve their function after a transplant. Studies have found that lungs and hearts can be preserved longer at this temperature without losing function. Specifically, one study found that 10°C might be the optimal temperature for storing lungs before a transplant. In this trial, one group will store kidneys at 10°C, potentially enhancing their function post-transplant compared to the traditional method of storing them on ice at 4°C, used in the other group. This approach may help kidneys function more effectively and last longer after surgery.678910

Who Is on the Research Team?

WC

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

I meet the specific requirements to join the study.
I am an adult waiting for a kidney transplant at Vanderbilt University Medical Center.
Participant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a kidney transplant with the organ stored at either 10°C or on ice

Immediate (day of transplant)
1 visit (in-person)

Post-operative Monitoring

Participants' urine is collected and analyzed 24 hours after surgery

1 day
1 visit (in-person)

Follow-up

Participants are monitored for delayed graft function and other outcomes

1 month
Multiple visits (in-person and virtual)

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

Group I: 10˚C deceased donor kidney storageExperimental Treatment1 Intervention
Group II: Conventional (ice storage) deceased donor kidney storageActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Traferox Technology Inc.

Collaborator

Citations

Lung Preservation and Perfusion Published Evidence

Preservation and Transport at 10°C is a Game Changer. Clinical and preclinical research has shown promising outcomes with organs preserved at 10°C.

The Advent of Semi-Elective Lung Transplantation ... - PMC

Total clinical preservation times of up to 24 hrs have been successfully achieved in organs stored at 10°C without hampering primary organ ...

Heart Preservation and Transport

X°Port Heart Preservation System. 10°C organ preservation has been demonstrated to extend the time window between procurement and transplant, which may allow: ...

X°Port Lung Preservation Solution

The solution cooled to 4°C to 8°C is used to perfuse the isolated organ immediately before its removal from the donor and/or immediately after its removal. The ...

10°C vs 4°C Lung Preservation RCT

10°C may be the optimal lung storage temperature, a prospective, multi-center, non-randomized clinical trial was conducted at University Health Network.

Deceased Donor Kidney Storage at 10 Celsius Versus ...

The goal of this clinical trial is to test how storage temperature of deceased donor kidneys affects kidney function after transplant in ...

X°Port Heart Preservation System

short and long-term outcomes in transplant recipients. ... A recent review on kidney ... Safety Data Sheet provided with these Instructions for Use for information ...

8.

traferox.com

traferox.com/

Traferox Technologies Inc.

Lungs stored at 10°C have been transplanted after 24 hours of storage with no increase in complication rates compared to 6-hour storage at 4°C.

Kidney Storage Temperature for Transplant Recipients

... Traferox XPort will have tolerable side effects & efficacy for patients with Ischemia Reperfusion Injury, Kidney Failure, Renal Disease, Kidney Transplant ...

Lung transplantation following controlled hypothermic storage ...

CHS seems safe and feasible despite the high-risk recipient and donor profiles, as well as extended preservation times. PGD3 at 72 h was ...