A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation

ID#: NCT06263023

Age: 16 - 75 years

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: April 19, 2024

End Date: September 01, 2025

Contact Information:
(303) 550-9989
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.
Eligibility: 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).