Transplant ComplicationTGINCT06063213
Using Transcriptional Assessment of Immune Response to Assess Immunosuppression After Liver Transplantation
An observational study of Transplant Complication, run by University of Florida at 1 site in United States.
Trial summary
To develop a prospective quantitative liver allograft monitoring protocol and retrospectively validate the use of Phenotypic personalized medicine (PPM) in immunosuppression dosing in liver transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Transplant Complication
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2023to 15 Oct 2026
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that are simultaneous Liver Kidney Transplant recipients that are one month post transplant. Patients that are Liver Transplant recipients that are one month post transplant.
Who may be able to join
- At least 18 years of age
- At least one-month post-transplant
- Recipient of a liver transplant alone or a simultaneous liver-kidney transplant
Who cannot join
- Unwilling to provide informed consent
- Recipient of a previous bone marrow or stem cell transplant
- Pregnant
- Unlikely to be able to comply with the study requirements, as determined by the PI
Trial locations and contacts
1 site in 1 country.
About this study
To develop a prospective quantitative liver allograft monitoring protocol and retrospectively validate the use of Phenotypic personalized medicine (PPM) in immunosuppression dosing in liver transplant recipients.
Read the detailed description
The investigators have developed a computational approach, Phenotypic Personalized Medicine (PPM), to utilize empiric clinical data to construct patient-specific visual maps that represent each individual's phenotypic response to drug treatment. Because this process does not require a priori knowledge of disease mechanism, it can effectively personalize drug dosing for any disease despite frequent changes to treatment regimens or patient physiology and genetics. In a pilot randomized controlled trial and its follow-up larger trial, the investigators have shown that transplant patients prospectively dosed with PPM-determined tacrolimus doses had improved drug trough-level management compared with standard of care physician-determined tacrolimus doses.
The ultimate objective in this project is to improve graft and patient outcomes in solid organ transplant recipients by using PPM to optimize immunosuppression dosing. The investigators hypothesize that existing and clinically validated quantifiable markers of immune state and allograft injury are clinically useful measures that can be employed with PPM as actionable analytical inputs for a dynamic optimization of patient-specific immunosuppression. The investigators will test this hypothesis by developing a prospective quantitative liver allograft monitoring protocol and validate the use of PPM in immunosuppression dosing in liver transplant recipients.
This study constitutes the first step in developing and then validating a personalized immunosuppression platform. The mechanism-independent nature of PPM ensures that it will be adaptive and actionable so that it can be applied to diverse sets of patients. The scalability of PPM also ensures that it can be deployed at a scale that can be applied widely to patients receiving care regardless of location.
- Conditions
- Transplant Complication
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 |
|---|---|---|
| Liver Transplant Group | Patients <1 month post-surgery for liver transplant only. | |
| Liver-Kidney Transplant Group | Patients <1 month post-surgery for simultaneous kidney-liver transplant only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodes of rejection
Patients will be followed for six months after transplantation according to standard of care. Episodes of biopsy proven rejection will be counted.
Measured: 6 months
Secondary outcomes (1)
Episodes of infection
Patients will be followed for six months after transplantation according to standard of care. Episodes of culture positive infection will be counted.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start15 Dec 2023
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant ComplicationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Transplant Genomics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063213
- Sponsor's protocol ID
- IRB202300021
- Acronym
- TGI
- Status last verified
- Mar 2026
- First submitted
- 26 Sep 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Transcriptional Assessment of Immune Response to Assess Immunosuppression After Liver Transplantation
- ClinicalTrials.gov ID
- NCT06063213
- Acronym / sponsor ID
- TGI / IRB202300021
- Conditions
- Transplant Complication
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Transplant Genomics, Inc.
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 2 Oct 2023 (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.
To develop a prospective quantitative liver allograft monitoring protocol and retrospectively validate the use of Phenotypic personalized medicine (PPM) in immunosuppression dosing in liver transplant recipients.
Detailed description
The investigators have developed a computational approach, Phenotypic Personalized Medicine (PPM), to utilize empiric clinical data to construct patient-specific visual maps that represent each individual's phenotypic response to drug treatment. Because this process does not require a priori knowledge of disease mechanism, it can effectively personalize drug dosing for any disease despite frequent changes to treatment regimens or patient physiology and genetics. In a pilot randomized controlled trial and its follow-up larger trial, the investigators have shown that transplant patients prospectively dosed with PPM-determined tacrolimus doses had improved drug trough-level management compared with standard of care physician-determined tacrolimus doses.
The ultimate objective in this project is to improve graft and patient outcomes in solid organ transplant recipients by using PPM to optimize immunosuppression dosing. The investigators hypothesize that existing and clinically validated quantifiable markers of immune state and allograft injury are clinically useful measures that can be employed with PPM as actionable analytical inputs for a dynamic optimization of patient-specific immunosuppression. The investigators will test this hypothesis by developing a prospective quantitative liver allograft monitoring protocol and validate the use of PPM in immunosuppression dosing in liver transplant recipients.
This study constitutes the first step in developing and then validating a personalized immunosuppression platform. The mechanism-independent nature of PPM ensures that it will be adaptive and actionable so that it can be applied to diverse sets of patients. The scalability of PPM also ensures that it can be deployed at a scale that can be applied widely to patients receiving care regardless of location.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver Transplant Group | – | –Patients <1 month post-surgery for liver transplant only. |
| Liver-Kidney Transplant Group | – | –Patients <1 month post-surgery for simultaneous kidney-liver transplant only. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are simultaneous Liver Kidney Transplant recipients that are one month post transplant. Patients that are Liver Transplant recipients that are one month post transplant.
Key inclusion criteria (3 listed)
- At least 18 years of age
- At least one-month post-transplant
- Recipient of a liver transplant alone or a simultaneous liver-kidney transplant
Key exclusion criteria (4 listed)
- Unwilling to provide informed consent
- Recipient of a previous bone marrow or stem cell transplant
- Pregnant
- Unlikely to be able to comply with the study requirements, as determined by the PI
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
Episodes of rejection
Time frame: 6 months
Patients will be followed for six months after transplantation according to standard of care. Episodes of biopsy proven rejection will be counted.
1 secondary outcome
Episodes of infection
Time frame: 6 months
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 4 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Transplant Complication, run by University of Florida 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 3 inclusion and 4 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 4 Mar 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?
Episodes of rejection (time frame: 6 months). 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 4 Mar 2026.