A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation

NCT06263023 | Active Not Recruiting

• 1 other identifier: 34L-CP-02-009
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Organ Preservation

Keywords

SNMP; Preservation; Transplantation; Kidney

Outcome Measures

Primary Outcomes (1)

• Transplant Allocation Success

  The primary objective for this study is a 50% success rate or higher for allocation of Hard-to-Place (HTP) kidneys to a participating transplant center after sNMP assessment at the Sponsor's central facility.

  1 year

Secondary Outcomes (9)

• 7-Day Delayed Graft Function (DGF)

  7 days post-transplant

• Graft Survival

  1- and 3-months post-transplant

• Patient Survival

  1- and 3-months post-transplant

• Serum Creatinine (sCr)

  1- and 3-months post-transplant

• eGFR

  1- and 3-months post-transplant

Study Arms (1)

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.

Other: Sub-Normothermic Machine Preservation and Assessment

Interventions

Sub-Normothermic Machine Preservation and Assessment 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.

Hard-to-Place (HTP) Donor Kidneys

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes hard-to-place (HTP) deceased donor kidneys retrieved from donation after brain death (DBD) and donation after circulatory death (DCD) donors aged 16- 75.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• 34 Lives, PBC: lead
• Indiana University Health: collaborator
• University of Miami: collaborator
• MOUNT SINAI HOSPITAL: collaborator
• University of Wisconsin, Madison: collaborator
• Erie County Medical Center, Buffalo, NY: collaborator
• Duke University Hospital, USA: collaborator
• Barnes-Jewish Hospital: collaborator
• Edward Hines Jr. VA Hospital: collaborator

Study Sites (8)

Edward Hines, Jr. VA Hospital

Chicago, Illinois, 60141, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

New York University Langone

New York, New York, 10016, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Related Publications (3)

• Kayler LK, Nie J, Noyes K. Hardest-to-place kidney transplant outcomes in the United States. Am J Transplant. 2021 Nov;21(11):3663-3672. doi: 10.1111/ajt.16739. Epub 2021 Jul 20.

  PMID: 34212471 BACKGROUND

• Hosgood SA, Callaghan CJ, Wilson CH, Smith L, Mullings J, Mehew J, Oniscu GC, Phillips BL, Bates L, Nicholson ML. Normothermic machine perfusion versus static cold storage in donation after circulatory death kidney transplantation: a randomized controlled trial. Nat Med. 2023 Jun;29(6):1511-1519. doi: 10.1038/s41591-023-02376-7. Epub 2023 May 25.

  PMID: 37231075 BACKGROUND

• Minor T, von Horn C, Gallinat A, Kaths M, Kribben A, Treckmann J, Paul A. First-in-man controlled rewarming and normothermic perfusion with cell-free solution of a kidney prior to transplantation. Am J Transplant. 2020 Apr;20(4):1192-1195. doi: 10.1111/ajt.15647. Epub 2019 Nov 10.

  PMID: 31599063 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Sponsor will collect kidney perfusate and urine samples at 90- and 120-minutes during SNMP to store in a -80C specimen freezer for future analysis or quality assurance. Sponsor will collect a 4mm core punch biopsy at the superior pole of the kidney for research use. Research testing of samples may include cytokine, ATP, metabolomics, transcriptomics, proteomics, genomics, dynamic contrast imagery (DCI) and/or hematoxylin and eosin (H\&E) histologic staining. All donor kidneys enrolled in this study will have legally authorized consent for organ donation for transplant and research purposes.

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Chris Jaynes

  34 Lives, PBC (Sponsor)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 16, 2024
• Study Start: April 19, 2024
• Primary Completion: March 25, 2025
• Study Completion (Estimated): March 25, 2028
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)