Staged Kidney Transplantation During Combined Heart/Kidney Transplantation

NCT06877169 | Recruiting FDA Device

• 1 other identifier: STUDY00003743
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Incidence of delayed graft function (DGF) of the kidney allograft

  Delayed graft function (DGF) of the kidney allograft is defined as dialysis within the first 7 days post-transplant and will be monitored for all participants.

  7 days

• Number of patients with at least one adverse event

  Safety endpoint will be assessed by monitoring for adverse events associated with either heart or kidney allografts within 90-days of initial operative event. Adverse events may include graft primary non-function, wound infection, urinary tract infection, ventilator-associated pneumonia, return to operating room, etc. Complications will be reported by Clavien-Dindo classification and analyzed as both those relating directly to the kidney transplant as well as overall incidence.

  90 days

Secondary Outcomes (9)

• Number of Patients with Heart Primary Graft Dysfunction

  24 hours

• 6 Month Kidney allograft function

  6 months

• 12-month Kidney Allograft Function

  12 months

• intensive care unit length of stay

  1 year

• Hospital Length of Stay

  1 year

Study Arms (1)

Delayed implantation with ex vivo machine perfusion of kidney allograft.

EXPERIMENTAL

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.

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

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.

Delayed implantation with ex vivo machine perfusion of kidney allograft.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (4)

• Kobashigawa J, Zuckermann A, Macdonald P, Leprince P, Esmailian F, Luu M, Mancini D, Patel J, Razi R, Reichenspurner H, Russell S, Segovia J, Smedira N, Stehlik J, Wagner F; Consensus Conference participants. Report from a consensus conference on primary graft dysfunction after cardiac transplantation. J Heart Lung Transplant. 2014 Apr;33(4):327-40. doi: 10.1016/j.healun.2014.02.027. Epub 2014 Mar 5.

  PMID: 24661451 BACKGROUND

• Jochmans I, Brat A, Davies L, Hofker HS, van de Leemkolk FEM, Leuvenink HGD, Knight SR, Pirenne J, Ploeg RJ; COMPARE Trial Collaboration and Consortium for Organ Preservation in Europe (COPE). Oxygenated versus standard cold perfusion preservation in kidney transplantation (COMPARE): a randomised, double-blind, paired, phase 3 trial. Lancet. 2020 Nov 21;396(10263):1653-1662. doi: 10.1016/S0140-6736(20)32411-9.

  PMID: 33220737 BACKGROUND

• Lutz AJ, Nagaraju S, Sharfuddin AA, Garcia JP, Saleem K, Mangus RS, Goggins WC. Simultaneous Heart-kidney Transplant With Planned Delayed Implantation of the Kidney Graft After Ex Vivo Perfusion. Transplantation. 2023 Sep 1;107(9):2043-2046. doi: 10.1097/TP.0000000000004661. Epub 2023 Jun 5.

  PMID: 37271866 BACKGROUND

• Ruzza A, Czer LS, Trento A, Esmailian F. Combined heart and kidney transplantation: what is the appropriate surgical sequence? Interact Cardiovasc Thorac Surg. 2013 Aug;17(2):416-8. doi: 10.1093/icvts/ivt172. Epub 2013 Apr 24.

  PMID: 23615433 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Justin A Steggerda, M.D.

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin A Steggerda, M.D.

CONTACT

310-423-3276; justin.steggerda@cshs.org

Noriko Ammerman, Pharm.D.

CONTACT

noriko.ammerman@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery, Division of Abdominal Transplant Surgery

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 14, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2035
• Last Updated: June 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)