NCT06263023

A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation

An Observational Study of a Dedicated Preservation and Assessment Service to Optimize Organ Utilization for Hard-to-Place Kidneys

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: 34 Lives, PBC · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to transplant hospitals.

Detailed description

This is an Observational study of a centralized kidney assessment facility providing brief sub-normothermic machine perfusion (SNMP) to HTP donor kidneys to provide transplant centers additional information for accepting HTP kidneys. This study is intended to collect data to evaluate the feasibility of a dedicated central service to determine if additional assessment data helps increase allocation to transplant centers. Transplantation will follow standard-of-care at each transplant center, including required post-transplant data collection, which must be reported to the OPTN registry by the center.

Conditions

• Organ Preservation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-19
• Primary completion: 2025-03-25
• Completion: 2028-03-25
• First posted: 2024-02-16
• Last updated: 2025-04-02

Locations

8 sites across 1 country: United States