A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation

Active, not recruitingOBSERVATIONAL
Enrollment

80

Participants

Timeline

Start Date

April 19, 2024

Primary Completion Date

March 25, 2025

Study Completion Date

March 25, 2028

Conditions
Organ Preservation
Interventions
OTHER

Sub-Normothermic Machine Preservation and Assessment

Human kidneys from HTP deceased donors will be transported to the Sponsor's central preservation and assessment facility and placed onto a machine perfusion system in a sterile operating room for a brief period of Sub-Normothermic Machine Perfusion (SNMP). Basic parameters including internal renal resistance, oxygen, and electrolyte levels will be recorded using standard point-of-care hospital analyzers. Accepted kidneys will be transported to a participating transplant center using a portable oxygenated LifePort Hypothermic Machine Preservation (HMP) device.

Trial Locations (8)

10016

New York University Langone, New York

10029

The Mount Sinai Hospital, New York

14215

Erie County Medical Center, Buffalo

27710

Duke University, Durham

46202

Indiana University Health, Indianapolis

53792

University of Wisconsin School of Medicine and Public Health, Madison

60141

Edward Hines, Jr. VA Hospital, Chicago

63110

Barnes-Jewish Hospital, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Indiana University Health

OTHER

collaborator

University of Miami

OTHER

collaborator

MOUNT SINAI HOSPITAL

OTHER

collaborator

University of Wisconsin, Madison

OTHER

collaborator

Erie County Medical Center, Buffalo, NY

UNKNOWN

collaborator

Duke University Hospital, USA

UNKNOWN

collaborator

Barnes-Jewish Hospital

OTHER

collaborator

Edward Hines Jr. VA Hospital

FED

lead

34 Lives, PBC

INDUSTRY

NCT06263023 - A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation | Biotech Hunter | Biotech Hunter