Organ PreservationOPTIMALNCT06263023
A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation
An observational study of Organ Preservation, run by 34 Lives, PBC at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Organ Preservation
- What is being tested?
- Sub-Normothermic Machine Preservation and Assessment
- How many people
- 80 participants
- Where
- 8 sitesUnited States
- Study dates
- 19 Apr 2024to 25 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Erie County Medical Center
Buffalo, New York, 14215
Edward Hines, Jr. VA Hospital
Chicago, Illinois, 60141
Duke University
Durham, North Carolina, 27710
Indiana University Health
Indianapolis, Indiana, 46202
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
New York University Langone
New York, New York, 10016
The Mount Sinai Hospital
New York, New York, 10029
Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: An Observational Study of a Dedicated Preservation and Assessment Service to Optimize Organ Utilization for Hard-to-Place Kidneys
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.
Read the detailed 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.
- Conditions
- Organ Preservation
- Being tested
- Sub-Normothermic Machine Preservation and Assessment
- Keywords
- SNMP, Preservation, Transplantation, Kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-Normothermic Machine Preservation and AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sub-Normothermic Machine Preservation and Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (9)
7-Day Delayed Graft Function (DGF)
Requirement for dialysis within first 7 days post-transplant
Measured: 7 days post-transplant
Graft Survival
Donor kidney survival
Measured: 1- and 3-months post-transplant
Patient Survival
Recipient survival
Measured: 1- and 3-months post-transplant
Serum Creatinine (sCr)
Recipient sCr
Measured: 1- and 3-months post-transplant
eGFR
Recipient estimated glomerular filtration rate
Measured: 1- and 3-months post-transplant
Long term data collection- Graft Survival
Graft survival
Measured: Annually, up to 3-years post-transplant
Long term data collection- Patient Survival
Patient survival
Measured: Annually, up to 3-years post-transplant
Long term data collection- Serum Creatinine
Recipient sCr
Measured: Annually, up to 3-years post-transplant
Long term data collection- eGFR
Recipient estimated glomerular filtration rate
Measured: Annually, up to 3-years post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start19 Apr 2024
- Primary completion25 Mar 2025
- Study completion25 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Organ PreservationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 34 Lives, PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University Health, University of Miami, MOUNT SINAI HOSPITAL, University of Wisconsin, Madison, Erie County Medical Center, Buffalo, NY, Duke University Hospital, USA, Barnes-Jewish Hospital, Edward Hines Jr. VA Hospital
- Responsible party
- Sponsor
- Investigators
- Chris Jaynes, Principal investigator, 34 Lives, PBC (Sponsor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263023
- Sponsor's protocol ID
- 34L-CP-02-009
- Acronym
- OPTIMAL
- Status last verified
- Mar 2025
- First submitted
- 5 Feb 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Standard data will be obtained from the Organ Procurement and Transplantation Network (OPTN), which is readily available to the public via request to the Health Resources Service Administration (HRSA), in de-identified form to protect privacy. These standard data include information about the organ donor, preservation procedure, the recipient's kidney transplant, and post-operative follow-up.
Publications
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.
PubMed 34212471Hosgood 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.
PubMed 37231075Minor 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.
PubMed 31599063
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of a Dedicated Preservation and Assessment Service to Optimize Organ Utilization for Hard-to-Place Kidneys
- ClinicalTrials.gov ID
- NCT06263023
- Acronym / sponsor ID
- OPTIMAL / 34L-CP-02-009
- Conditions
- Organ Preservation
- Keywords
- SNMP, Preservation, Transplantation, Kidney
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- 34 Lives, PBCIndustry (pharma, biotech, devices)
- Collaborators
- Indiana University Health, University of Miami, MOUNT SINAI HOSPITAL, University of Wisconsin, Madison, Erie County Medical Center, Buffalo, NY, Duke University Hospital, USA, Barnes-Jewish Hospital, Edward Hines Jr. VA Hospital
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2028 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hard-to-Place (HTP) Donor Kidneys | – | Other: Sub-Normothermic Machine Preservation and AssessmentThe 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. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sub-Normothermic Machine Preservation and AssessmentHuman 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. | Other | Hard-to-Place (HTP) Donor Kidneys |
Primary outcome
Transplant Allocation Success
Time frame: 1 year
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.
9 secondary outcomes
7-Day Delayed Graft Function (DGF)
Time frame: 7 days post-transplant
Graft Survival
Time frame: 1- and 3-months post-transplant
Patient Survival
Time frame: 1- and 3-months post-transplant
Serum Creatinine (sCr)
Time frame: 1- and 3-months post-transplant
eGFR
Time frame: 1- and 3-months post-transplant
Long term data collection- Graft Survival
Time frame: Annually, up to 3-years post-transplant
Long term data collection- Patient Survival
Time frame: Annually, up to 3-years post-transplant
Long term data collection- Serum Creatinine
Time frame: Annually, up to 3-years post-transplant
Long term data collection- eGFR
Time frame: Annually, up to 3-years post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 34212471Kayler 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.
- Background: PubMed 37231075Hosgood 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.
- Background: PubMed 31599063Minor 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.
- Individual participant dataSharing planned: No. Standard data will be obtained from the Organ Procurement and Transplantation Network (OPTN), which is readily available to the public via request to the Health Resources Service Administration (HRSA), in de-identified form to protect privacy. These standard data include information about the organ donor, preservation procedure, the recipient's kidney transplant, and post-operative follow-up.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Jaynes principal investigator
34 Lives, PBC (Sponsor)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Preservation, run by 34 Lives, PBC at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant Allocation Success (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06263023, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.