A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-19

Study Completion Date

2028-03-25

Brief Summary

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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.

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Detailed Description

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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

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Organ Preservation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hard-to-Place (HTP) Donor Kidneys

The study will be open to all eligible HTP kidneys from male and female donors at all participating Organ Procurement Organization (OPO) study sites. Consent for both organ donation for transplant and medical research will be obtained from the legally authorized party (LAP) by the OPO Coordinator using industry standard consent procedures and documents.

Sub-Normothermic Machine Preservation and Assessment

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Be considered HTP, by receiving refusals from every transplant center within the 250 nm allocation radius or similar definition by the local OPO.
* From a Male or female deceased donor, aged 16- 75 years old.
* Kidney initially procured, preserved, and packaged with intent to transplant.
* LAP provides informed consent for organ donation for transplant and research purposes.
* The HTP donor kidney must be allocated to a participating transplant center by a participating OPO, and the transplant center makes the decision to send kidney to Sponsor's central preservation and assessment facility for SNMP assessment and preservation prior to determining suitability for allocation.

Exclusion Criteria

* From a Donor with pre-admission diagnosis of end stage renal failure.
* Obvious surgical damage to artery(s), vein(s), or ureter(s) preventing machine perfusion.
* From a donor with confirmed HIV (+), HBVSAg (+) and/or HCV NAT (+) serology results.
* No LAP consent for both transplant and research purposes.
* Cannot arrive to Sponsor's central preservation and assessment facility before reaching 24 hours of cold ischemic time (CIT).

Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No