A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation

Organ Preservation Clinical Trial

— OPTIMAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263023
• Other study ID #: 34L-CP-02-009
• Status: Recruiting
• Start date: April 19, 2024
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: 34 Lives, PBC
• Contact: CEO
• Phone: (303) 550-9989
• Email: study[@]34lives.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

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).

Related Conditions & MeSH terms

• Organ Preservation

Intervention

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.

Locations

Country	Name	City	State
United States	Indiana University Health	Indianapolis	Indiana
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin
United States	Miami Transplant Institute, University of Miami Miller School of Medicine	Miami	Florida
United States	The Mount Sinai Hospital	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
34 Lives, PBC	Indiana University Health, MOUNT SINAI HOSPITAL, University of Miami, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7-Day Delayed Graft Function (DGF)	Requirement for dialysis within first 7 days post-transplant	7 days post-transplant
Secondary	Graft Survival	Donor kidney survival	1- and 3-months post-transplant
Secondary	Patient Survival	Recipient survival	1- and 3-months post-transplant
Secondary	Serum Creatinine (sCr)	Recipient sCr	1- and 3-months post-transplant
Secondary	eGFR	Recipient estimated glomerular filtration rate	1- and 3-months post-transplant
Secondary	Long term data collection- Graft Survival	Graft survival	Annually, up to 3-years post-transplant
Secondary	Long term data collection- Patient Survival	Patient survival	Annually, up to 3-years post-transplant
Secondary	Long term data collection- Serum Creatinine	Recipient sCr	Annually, up to 3-years post-transplant
Secondary	Long term data collection- eGFR	Recipient estimated glomerular filtration rate	Annually, up to 3-years post-transplant