Staged Kidney Transplantation During Combined Heart/Kidney Transplantation
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult patients (18 years or older) undergoing combined heart and kidney transplantation at Cedars-Sinai Medical Center.
Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Justin A Steggerda, M.D.
justin.steggerda@cshs.org
310-423-3276
Backup
Noriko Ammerman, Pharm.D.
noriko.ammerman@cshs.org
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2035-02-28
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Cedars-Sinai Medical Center