Staged kidney implantation with hypothermic oxygenated machine perfusion during combined heart and kidney transplants
Official title: Staged Kidney Transplantation During Combined Heart/Kidney Transplantation
Run by Cedars-Sinai Medical Center · NCT06877169 · Data updated 2026-11-12
This trial will test whether keeping the donor kidney on oxygenated machine perfusion and implanting it later helps adults who are receiving both a heart and a kidney transplant.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Status | Recruiting |
| Started | April 7, 2025 |
| Main results expected | February 28, 2027 |
| Study ends | February 28, 2035 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT06877169 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults at Cedars-Sinai scheduled for a planned combined heart and kidney transplant who can undergo staged (delayed) kidney implantation and have not opted out of research.
✕Probably not a fit
Patients who require immediate simultaneous heart and kidney implantation for medical necessity, those flagged as research opt-out in the electronic record, or those unable to return for post-operative follow-up are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Combined heart and kidney transplantation treats patients with advanced heart failure and kidney disease but poses logistical and physiologic challenges that can harm the kidney graft. Anticoagulation, inotropes, and hemodynamic instability during heart implantation can worsen ischemia-reperfusion injury, while delaying implantation increases cold ischemic time. This study uses hypothermic oxygenated ex vivo machine perfusion to preserve the donor kidney and implements a planned delayed (staged) implantation to allow recipient stabilization after heart transplant. Outcomes include safety endpoints and measures of kidney graft function such as incidence of delayed graft function and need for dialysis in the first week.
Why it matters
Potential benefit: If successful, this approach could reduce delayed graft function and improve early kidney graft survival after combined heart-kidney transplants.
How similar studies have gone: Hypothermic oxygenated machine perfusion has shown promise in reducing ischemia-reperfusion injury and delayed graft function in other kidney transplant settings, but planned delayed implantation during combined heart-kidney transplantation is relatively novel with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Cedars-Sinai Medical Center
Los Angeles, California, United States Recruiting
Study contacts
- Principal investigator: Justin A Steggerda, M.D. — Cedars-Sinai Medical Center
- Study coordinator: Justin A Steggerda, M.D.
- Email: justin.steggerda@cshs.org
- Phone: 310-423-3276
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.