Staged Kidney Transplantation During Combined Heart/Kidney Transplantation

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT06877169
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 7, 2025
Status verified
Mar 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2035

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Incidence of delayed graft function (DGF) of the kidney allograft [ Time Frame: 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Justin A Steggerda, M.D.
[email protected]
310-423-3276
Justin A Steggerda, M.D. (PRINCIPAL_INVESTIGATOR)
Tyler Gunn, M.D. (SUB_INVESTIGATOR)
Steven A Wisel, M.D. (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Chronic kidney diseaseHeart failure
By specialty
NephrologyKidney diseaseCardiologyHeart disease
By research site
Cedars-Sinai Medical Center· Los Angeles, CA

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