Recruiting

Ex Vivo Machine Perfusion

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT06877169

Conditions

Heart Failure

Chronic Kidney Disease

End-stage Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Planned delayed implantation of kidney allograft with ex vivo machine perfusion kidney preservation.

Study Details

Brief summary:

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.

Conditions

Heart Failure

Chronic Kidney Disease

End-stage Kidney Disease

Study ID

NCT06877169

Start date

Apr 7, 2025

Status verified date

Jul, 2026

Completion date

Feb 28, 2035

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients (18 years or older) undergoing combined heart and kidney transplantation at Cedars-Sinai Medical Center.

Exclusion Criteria:

  • Patients who undergo simultaneous heart/kidney transplantation in a single operative event due to medical necessity will be excluded.
  • Patients with medical records flagged as "break-the-glass" or "research opt-out" within the center's electronic health record.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Delayed implantation with ex vivo machine perfusion of kidney allograft.

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.

Interventions

Planned delayed implantation of kidney allograft with ex vivo machine perfusion kidney preservation.

During combined heart and kidney transplantation, heart and kidney allografts may be implanted during a single operative event, or with delayed kidney implantation in a second operative event. Timing of the delay is often determined by recipient stability and kidney availability; however, clinicians must balance recipient factors with accumulating cold ischemic time of the kidney allograft. This study uses hypothermic oxygenated machine perfusion to reduce ischemic injury to the kidney allograft and allow for improved recipient stability with planned delayed implantation of the kidney graft. Delays will allow for at least 6 hours of hypothermic oxygenated machine perfusion prior to implantation.

Primary outcome measure

  • Incidence of delayed graft function (DGF) of the kidney allograft [ Time Frame: 7 days ]
  • Number of patients with at least one adverse event [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Noriko Ammerman, Pharm.D.

noriko.ammerman@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Principal Investigator:

Justin A Steggerda, M.D.

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • combined heart and kidney transplant
  • simultaneous heart and kidney transplant
  • hypothermic oxygenated machine perfusion
  • organ preservation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-07-24.