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Staged Kidney Transplantation During Combined Heart/Kidney Transplantation

NCT06877169 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-03

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Justin A Steggerda, M.D. · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-07
Primary Completion
2027-02-28
Completion
2035-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06877169 on ClinicalTrials.gov