Machine Preservation for Kidney Disease

Overseen By Noriko Ammerman, Pharm.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Simultaneous transplant, Break-the-glass, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to preserve and transplant kidneys for individuals receiving both a heart and kidney transplant. The focus is on using a machine to maintain the kidney's health outside the body before transplantation, potentially making the procedure safer and more effective. Suitable candidates are adults undergoing both a heart and kidney transplant at Cedars-Sinai Medical Center. This approach slightly delays kidney implantation to ensure optimal timing for the patient's condition. As an unphased trial, this study allows patients to contribute to innovative research that could enhance transplant outcomes.

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 prior data suggests that this method is safe for kidney transplantation?

Research has shown that using a special machine to maintain kidney health before a transplant is generally safe. One study found that hypothermic oxygenated machine perfusion (HOPE) can reduce the risk of delayed graft function, where the new kidney takes longer to start working. This suggests the method might protect the kidney from harm during storage.

Another study discovered that adding oxygen while keeping the kidney cold improved its performance after the transplant, increasing the likelihood of the kidney functioning well once transplanted.

Overall, these findings suggest that this method is generally safe and might enhance the success of kidney transplants. However, as with any medical treatment, risks are involved. It is important to discuss these risks with a healthcare provider before deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this kidney preservation technique because it uses hypothermic oxygenated machine perfusion (HOPE) to keep the kidney allograft in optimal condition before transplantation. Unlike standard methods that rely on simple cold storage, this technique actively circulates oxygenated fluid at low temperatures, potentially reducing damage and improving the kidney's viability. This approach offers the potential for more flexible timing of transplants, allowing doctors to focus on the recipient's health stability, which could lead to better overall outcomes.

What evidence suggests that ex vivo machine perfusion is effective for kidney preservation?

Research has shown that using a special technique called ex vivo machine perfusion, particularly with hypothermic oxygenated machine perfusion (HOPE), can improve kidney transplant outcomes. In this trial, participants will undergo delayed implantation with ex vivo machine perfusion of the kidney allograft. Studies have found that this method can reduce the risk of delayed graft function, where the new kidney doesn't start working immediately, requiring dialysis during the first week after the transplant. The machine perfusion technique keeps the kidney healthy by supplying it with oxygen and maintaining a cold temperature before placement in the body. This method is promising because it can enhance kidney function and reduce post-surgery complications. Overall, early evidence suggests that this technique could increase the success rates of kidney transplants, especially in complex surgeries involving both heart and kidney transplants. ^{2 4 6 7 8}

Who Is on the Research Team?

Justin A Steggerda, M.D.

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Delayed implantation with ex vivo machine perfusion of kidney allograft. Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6913689/

Hypothermic Oxygenated Machine Perfusion of Extended ... The secondary endpoints of the study include: (1) duration of DGF (defined as the period between kidney transplant and last dialysis in days) and functional DGF ...

2. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.808719/full

Ex-vivo Kidney Machine Perfusion: Therapeutic Potential In this comprehensive review current state of evidence regarding ex-vivo kidney machine perfusion and its capacity in kidney graft treatment is presented.

3. nature.com nature.com/articles/s41598-020-62979-9

Hypothermic Oxygenated New Machine Perfusion System ... We hereby describe a clinical trial of ex-vivo hypothermic oxygenated perfusion (HOPE) in the field of liver (LT) and kidney transplantation (KT) from Extended ...

4. ajkd.org ajkd.org/article/S0272-6386(25)00047-2/fulltext

Machine Perfusion in Deceased Donor Kidney ... The use of nonoxygenated HMP reduced the rate of delayed graft function, defined as need for dialysis in the first week post-transplant, ...

5. kireports.org kireports.org/article/S2468-0249(25)00413-9/fulltext

Normothermic Kidney Perfusion: Current Status and ... Targeted delivery of galunisertib using machine perfusion reduces fibrogenesis in an integrated ex vivo renal transplant and fibrogenesis model. Br J ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38637312/

Ex vivo kidney machine perfusion: meta-analysis of ... Hypothermic machine perfusion reduces delayed graft function risks and normothermic approaches show promise.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1600613522259413

Renal Transplantation After Ex Vivo Normothermic Perfusion EVNP kidneys were perfused for an average of 63 ± 16 min and all were transplanted successfully. The delayed graft function rate (DGF), defined as the ...

8. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(20)32411-9/abstract

Oxygenated versus standard cold perfusion preservation in ... This study aimed to investigate whether supplemental oxygen during hypothermic machine perfusion (HMP) could improve the outcome of kidneys ...