A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation (OPTIMAL)

34 Lives, PBC

Status: Active, not recruiting

Conditions: Organ Preservation

Treatments: Other: Sub-Normothermic Machine Preservation and Assessment

Study type: Observational

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT06263023

34L-CP-02-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Donor Kidney 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.

Donor Kidney 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).

Trial design

80 participants in 1 patient group

Hard-to-Place (HTP) Donor Kidneys

Description:

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.

Treatment:

Other: Sub-Normothermic Machine Preservation and Assessment