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Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03527238
Acronym
PPM - Pro
Enrollment
62
Registered
2018-05-17
Start date
2018-09-21
Completion date
2021-08-31
Last updated
2021-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant, Liver Transplant

Keywords

Phenotypic Precision Medicine (PPM), Tacrolimus, Calcineurin Inhibitors

Brief 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.

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.

Interventions

OTHERPPM-based Computation Assisted Drug Dosing

Tacrolimus dosing based on application of PPM.

DRUGTacrolimus

Dosing of calcineurin inhibitor, tacrolimus

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* adults undergoing liver and/or kidney transplantation

Exclusion criteria

* transplant patients with contraindications to tacrolimus

Design outcomes

Primary

MeasureTime frameDescription
Tacrolimus Target Trough Level Maintenance2 weeksPercentage of Days Far (\> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level

Countries

Singapore, United States

Participant flow

Participants by arm

ArmCount
Standard of Care
Standard of Care Tacrolimus Drug Dosing Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus
31
Phenotypic Precision Medicine (PPM)
PPM-based Computation Assisted Drug Dosing PPM-based Computation Assisted Drug Dosing: Tacrolimus dosing based on application of PPM. Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus
31
Total62

Baseline characteristics

CharacteristicStandard of CarePhenotypic Precision Medicine (PPM)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants6 Participants11 Participants
Age, Categorical
Between 18 and 65 years
26 Participants25 Participants51 Participants
Age, Continuous57 years58 years57.5 years
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants4 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
29 Participants27 Participants56 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
2 Participants0 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
29 Participants30 Participants59 Participants
Region of Enrollment
United States
31 participants31 participants62 participants
Sex: Female, Male
Female
14 Participants13 Participants27 Participants
Sex: Female, Male
Male
17 Participants18 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 31
other
Total, other adverse events
6 / 316 / 31
serious
Total, serious adverse events
0 / 310 / 31

Outcome results

Primary

Tacrolimus Target Trough Level Maintenance

Percentage of Days Far (\> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level

Time frame: 2 weeks

ArmMeasureValue (MEAN)Dispersion
Standard of CareTacrolimus Target Trough Level Maintenance38.4 percentage of daysStandard Deviation 27.4
Phenotypic Precision Medicine (PPM)Tacrolimus Target Trough Level Maintenance24.2 percentage of daysStandard Deviation 19.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026