20 Participants Needed

Machine Preservation for Kidney Disease

JA
NA
Overseen ByNoriko Ammerman, Pharm.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cedars-Sinai Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

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 data supports the effectiveness of the treatment Planned delayed implantation of kidney allograft with ex vivo machine perfusion kidney preservation?

Research shows that using machine perfusion to preserve kidneys can reduce the risk of delayed graft function (when the kidney takes longer to start working) and improve the survival of the transplanted kidney compared to traditional cold storage methods.12345

Is machine perfusion for kidney preservation safe for humans?

Machine perfusion for kidney preservation has been shown to be safe in studies, with benefits like reduced risk of delayed graft function and improved one-year graft survival compared to cold storage.12567

How is the treatment of planned delayed implantation of kidney allograft with ex vivo machine perfusion kidney preservation different from other treatments for kidney disease?

This treatment is unique because it uses ex vivo machine perfusion, a novel technique that preserves kidneys outside the body by circulating a special fluid through them, which can improve kidney function and survival compared to traditional cold storage methods.12346

What is the purpose of this trial?

The primary purpose of this study is to evaluate the safety and efficacy of ex vivo machine perfusion with staged implantation of kidney allografts during combined heart/kidney transplantation.

Research Team

JA

Justin A Steggerda, M.D.

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for patients with severe heart and kidney conditions who need both a heart and kidney transplant. They should be stable enough to undergo staged surgeries, first receiving the heart then the kidney after some time.

Inclusion Criteria

I am an adult scheduled for heart and kidney transplant at Cedars-Sinai.

Exclusion Criteria

Patients with medical records flagged as 'break-the-glass' or 'research opt-out' within the center's electronic health record.
I have not had a heart and kidney transplant at the same time.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Heart Transplantation

Participants undergo heart transplantation as part of the combined heart/kidney transplantation procedure

Immediate
1 visit (in-person)

Delayed Kidney Transplantation

Participants receive delayed kidney transplantation with hypothermic oxygenated machine perfusion (HOPE) for kidney preservation

6 hours of HOPE preservation before transplantation

Follow-up

Participants are monitored for safety and effectiveness after transplantation, including monitoring for delayed graft function and adverse events

1 year
Regular follow-up visits

Treatment Details

Interventions

  • Planned delayed implantation of kidney allograft with ex vivo machine perfusion kidney preservation
Trial Overview The study tests if keeping a donated kidney on a machine that mimics body conditions (ex vivo perfusion) before implantation is safe and works well when done in stages during combined heart/kidney transplants.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Delayed implantation with ex vivo machine perfusion of kidney allograft.Experimental Treatment1 Intervention
Patients presenting for heart/kidney transplantation who consent to participate will be enrolled in this prospective, open-label, single-arm trial to undergo heart transplantation with planned delayed kidney transplantation with machine perfusion of the kidney allograft. Kidneys will be preserved using hypothermic oxygenated machine perfusion (HOPE) prior to transplantation. Timing of kidney implantation will be determined by recipient stability (e.g., vasopressor and inotrope requirements, coagulopathy, heart graft function) and allow for at least 6 hours of HOPE preservation. Both heart and kidney transplant procedures will follow standard of care techniques.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials
523
Recruited
165,000+

References

Ex-vivo machine perfusion for kidney preservation. [2019]
A new device towards intermediate term kidney preservation--an experimental study. [2009]
Combining Oxygenated Cold Perfusion With Normothermic Ex Vivo Perfusion Improves the Outcome of Donation After Circulatory Death Porcine Kidney Transplantation. [2023]
The cost-effectiveness of organ preservation methods in renal transplantation: US projections based on the machine preservation trial. [2009]
Machine perfusion versus cold storage for preservation of kidneys from expanded criteria donors after brain death. [2011]
Preservation of cadaveric kidneys. Cold storage or machine perfusion? [2019]
Randomized Trial of Machine Perfusion Versus Cold Storage in Recipients of Deceased Donor Kidney Transplants With High Incidence of Delayed Graft Function. [2022]
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