Liver TransplantPhase 2PPM - ProNCT03527238
Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine
A Phase 2 study testing PPM-based Computation Assisted Drug Dosing and Tacrolimus in people with Liver Transplant and Kidney Transplant, run by University of Florida at 3 sites in 2 countries.
Trial summary
Clinical trial applying Phenotypic Precision Medicine (PPM) to tacrolimus dosing in liver and/or kidney transplant recipients to show improvement in maintaining drug trough levels within the target range. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Liver Transplant, Kidney Transplant
- What is being tested?
- PPM-based Computation Assisted Drug Dosing and Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 21 Sep 2018to 31 Aug 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults undergoing liver and/or kidney transplantation
Who cannot join
- transplant patients with contraindications to tacrolimus
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
UF Health at the University of Florida
Gainesville, Florida, 32610
UCLA
Los Angeles, California, 90095
About this study
Clinical trial applying Phenotypic Precision Medicine (PPM) to tacrolimus dosing in liver and/or kidney transplant recipients to show improvement in maintaining drug trough levels within the target range.
Read the detailed description
The introduction of calcineurin inhibitors like tacrolimus has greatly reduced the incidence of acute rejection, improving graft and patient survival after transplantation. However, tacrolimus, one of the most widely used immunosuppressants and a mainstay of solid organ transplantation, has a narrow therapeutic index and wide pharmacokinetic variability. As such, there is a clear need for precision medicine to address post-transplant immunosuppression.
The study team has developed a powerful platform [Phenotypic Precision Medicine (PPM)] that utilizes patient-specific clinical data which represents each patient's response to drug treatment. This platform can efficiently prescribe precise and optimized drug doses despite the frequent changes to patient treatment regimens following transplantation. This potentially can have a profound effect on drug metabolism.
The aim of this project is to use PPM to uncover valuable and previously unknown information pertaining to patient dose requirements and correlate them with patient clinical and other contextual information. This study is also expected to reveal vital patient subpopulation information; and any future discovery of quantitative biomarkers as measures of immunosuppression will serve as a gateway towards even more effective personalized and relevant drug dosing.
- Conditions
- Liver Transplant, Kidney Transplant
- Being tested
- PPM-based Computation Assisted Drug Dosing, Tacrolimus
- Keywords
- Phenotypic Precision Medicine (PPM), Tacrolimus, Calcineurin Inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPM-based Computation Assisted Drug DosingOther
Also called Computation based dosing
Tacrolimus dosing based on application of PPM.
TacrolimusDrug
Dosing of calcineurin inhibitor, tacrolimus
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of Care Tacrolimus Drug Dosing Receives: Drug: Tacrolimus |
| Phenotypic Precision Medicine (PPM) | Experimental | PPM-based Computation Assisted Drug Dosing Receives: Other: PPM-based Computation Assisted Drug Dosing; Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tacrolimus Target Trough Level Maintenance
Percentage of Days Far (> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start21 Sep 2018
- Primary completion2 Jun 2020
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Zarrinpar, MD PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527238
- Sponsor's protocol ID
- IRB201800053 -N -A
- Other IDs
- 1R21DK116140-01
- Acronym
- PPM - Pro
- Status last verified
- Dec 2021
- First submitted
- 4 May 2018
- Last updated
- 10 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Khong J, Lee M, Warren C, Kim UB, Duarte S, Andreoni KA, Shrestha S, Johnson MW, Battula NR, McKimmy DM, Beduschi T, Lee JH, Li DM, Ho CM, Zarrinpar A. Tacrolimus dosing in liver transplant recipients using phenotypic personalized medicine: A phase 2 randomized clinical trial. Nat Commun. 2025 May 16;16(1):4558. doi: 10.1038/s41467-025-59739-6.
PubMed 40379675
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine
- ClinicalTrials.gov ID
- NCT03527238
- Acronym / sponsor ID
- PPM - Pro / IRB201800053 -N -A
- Conditions
- Liver Transplant, Kidney Transplant
- Keywords
- Phenotypic Precision Medicine (PPM), Tacrolimus, Calcineurin Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Posted 10 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical trial applying Phenotypic Precision Medicine (PPM) to tacrolimus dosing in liver and/or kidney transplant recipients to show improvement in maintaining drug trough levels within the target range.
Detailed description
The introduction of calcineurin inhibitors like tacrolimus has greatly reduced the incidence of acute rejection, improving graft and patient survival after transplantation. However, tacrolimus, one of the most widely used immunosuppressants and a mainstay of solid organ transplantation, has a narrow therapeutic index and wide pharmacokinetic variability. As such, there is a clear need for precision medicine to address post-transplant immunosuppression.
The study team has developed a powerful platform [Phenotypic Precision Medicine (PPM)] that utilizes patient-specific clinical data which represents each patient's response to drug treatment. This platform can efficiently prescribe precise and optimized drug doses despite the frequent changes to patient treatment regimens following transplantation. This potentially can have a profound effect on drug metabolism.
The aim of this project is to use PPM to uncover valuable and previously unknown information pertaining to patient dose requirements and correlate them with patient clinical and other contextual information. This study is also expected to reveal vital patient subpopulation information; and any future discovery of quantitative biomarkers as measures of immunosuppression will serve as a gateway towards even more effective personalized and relevant drug dosing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: TacrolimusStandard of Care Tacrolimus Drug Dosing |
| Phenotypic Precision Medicine (PPM) | Experimental | Other: PPM-based Computation Assisted Drug Dosing, Drug: TacrolimusPPM-based Computation Assisted Drug Dosing |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults undergoing liver and/or kidney transplantation
Key exclusion criteria (1 listed)
- transplant patients with contraindications to tacrolimus
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 |
|---|---|---|
| PPM-based Computation Assisted Drug DosingAlso: Computation based dosingTacrolimus dosing based on application of PPM. | Other | Phenotypic Precision Medicine (PPM) |
| TacrolimusDosing of calcineurin inhibitor, tacrolimus | Drug | Phenotypic Precision Medicine (PPM), Standard of Care |
Primary outcome
Tacrolimus Target Trough Level Maintenance
Time frame: 2 weeks
Percentage of Days Far (> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40379675Khong J, Lee M, Warren C, Kim UB, Duarte S, Andreoni KA, Shrestha S, Johnson MW, Battula NR, McKimmy DM, Beduschi T, Lee JH, Li DM, Ho CM, Zarrinpar A. Tacrolimus dosing in liver transplant recipients using phenotypic personalized medicine: A phase 2 randomized clinical trial. Nat Commun. 2025 May 16;16(1):4558. doi: 10.1038/s41467-025-59739-6.
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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.
Ali Zarrinpar, MD PhD principal investigator
University of Florida
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PPM-based Computation Assisted Drug Dosing and Tacrolimus in people with Liver Transplant and Kidney Transplant, run by University of Florida at 3 sites in 2 countries.
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: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Singapore. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tacrolimus Target Trough Level Maintenance (time frame: 2 weeks). 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 NCT03527238, which also lists 1 linked publication.
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 10 Dec 2021.