Normothermic Machine Perfusion (NMP) of Deceased Donor KidneysNCT07530991
Registry Analysis of Deceased Donor Kidney Transplant Outcomes
An observational study of Normothermic Machine Perfusion (NMP) of Deceased Donor Kidneys, run by Chris Jaynes at 1 site in United States.
Trial summary
This study uses existing transplant data obtained from a national public donor registry operated by the Organ Procurement and Transplant Network (OPTN) under Health Resources and Services Agency (HRSA) to evaluate outcomes associated with normothermic machine perfusion (NMP) of deceased donor kidneys. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Normothermic Machine Perfusion (NMP) of Deceased Donor Kidneys
- How many people
- 3,500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 30 Apr 2029
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: End stage renal disease, receiving a kidney transplant.
Who may be able to join
- Requires kidney transplantation
Who cannot join
- > 15 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Registry Analysis of Deceased Donor Kidney Transplant Outcomes With Normothermic Machine Perfusion (NMP)
This study uses existing transplant data obtained from a national public donor registry operated by the Organ Procurement and Transplant Network (OPTN) under Health Resources and Services Agency (HRSA) to evaluate outcomes associated with normothermic machine perfusion (NMP) of deceased donor kidneys. Currently, there is no method to study NMP kidney outcomes using the National Scientific Registry for Transplant Recipients (SRTR) national public registry, because no data field exists to identify which kidneys received NMP.
Read the detailed description
This is a retrospective observational study using existing data from the Scientific Registry of Transplant Recipients (SRTR)/ Organ Procurement and Transplant Network (OPTN) public registry following a Research Plan approved by Health Resources \& Services Agency (HRSA).
- Keywords
- NMP, Normothermic, Perfusion, Kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NMP Kidney Recipients | Patients receiving a kidney preserved and assessed using NMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed Graft Function
Requirement for dialysis immediately post kidney transplantation
Measured: 7 days post-transplantation
Delayed Graft Function (DGF)
Requirement for dialysis within 7 days post kidney transplantation
Measured: 7 days
Secondary outcomes (1)
Serum creatinine
Serum creatinine level
Measured: Up to 3 years post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Apr 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normothermic Machine Perfusion (NMP) of Deceased Donor KidneysStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chris Jaynes
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Chris Jaynes, 34 Lives, PBC
- Investigators
- Henri Leuvenink, PhD, Study chair, 34 Lives, PBCJacqueline Garonzik-Wang, MD, PhD, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530991
- Sponsor's protocol ID
- 34L-CP-02-021
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a registry-only, Non Human Subjects Research (NHSR) study. No IPD information will be available to any investigator in this study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Analysis of Deceased Donor Kidney Transplant Outcomes With Normothermic Machine Perfusion (NMP)
- ClinicalTrials.gov ID
- NCT07530991
- Acronym / sponsor ID
- 34L-CP-02-021
- Keywords
- NMP, Normothermic, Perfusion, Kidney
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Chris JaynesIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 15 Apr 2026 (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 study uses existing transplant data obtained from a national public donor registry operated by the Organ Procurement and Transplant Network (OPTN) under Health Resources and Services Agency (HRSA) to evaluate outcomes associated with normothermic machine perfusion (NMP) of deceased donor kidneys. Currently, there is no method to study NMP kidney outcomes using the National Scientific Registry for Transplant Recipients (SRTR) national public registry, because no data field exists to identify which kidneys received NMP.
Detailed description
This is a retrospective observational study using existing data from the Scientific Registry of Transplant Recipients (SRTR)/ Organ Procurement and Transplant Network (OPTN) public registry following a Research Plan approved by Health Resources \& Services Agency (HRSA).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NMP Kidney Recipients | – | –Patients receiving a kidney preserved and assessed using NMP |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- End stage renal disease, receiving a kidney transplant.
Key inclusion criteria (1 listed)
- Requires kidney transplantation
Key exclusion criteria (1 listed)
- > 15 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delayed Graft Function
Time frame: 7 days post-transplantation
Requirement for dialysis immediately post kidney transplantation
Delayed Graft Function (DGF)
Time frame: 7 days
Requirement for dialysis within 7 days post kidney transplantation
1 secondary outcome
Serum creatinine
Time frame: Up to 3 years post-transplantation
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 15 Apr 2026.
- Individual participant dataSharing planned: No. This is a registry-only, Non Human Subjects Research (NHSR) study. No IPD information will be available to any investigator in this study.
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.
Henri Leuvenink, PhD study chair
34 Lives, PBC
Jacqueline Garonzik-Wang, MD, PhD study chair
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normothermic Machine Perfusion (NMP) of Deceased Donor Kidneys, run by Chris Jaynes at 1 site 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Delayed Graft Function (time frame: 7 days post-transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.