Kidney Transplant, Liver Transplant
Conditions
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
Tacrolimus dosing based on application of PPM.
Dosing of calcineurin inhibitor, tacrolimus
Sponsors
Study design
Eligibility
Inclusion criteria
* adults undergoing liver and/or kidney transplantation
Exclusion criteria
* transplant patients with contraindications to tacrolimus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tacrolimus Target Trough Level Maintenance | 2 weeks | Percentage of Days Far (\> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level |
Countries
Singapore, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 62 |
Baseline characteristics
| Characteristic | Standard of Care | Phenotypic Precision Medicine (PPM) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 25 Participants | 51 Participants |
| Age, Continuous | 57 years | 58 years | 57.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 27 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 30 Participants | 59 Participants |
| Region of Enrollment United States | 31 participants | 31 participants | 62 participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 6 / 31 | 6 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 |
Outcome results
Tacrolimus Target Trough Level Maintenance
Percentage of Days Far (\> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Tacrolimus Target Trough Level Maintenance | 38.4 percentage of days | Standard Deviation 27.4 |
| Phenotypic Precision Medicine (PPM) | Tacrolimus Target Trough Level Maintenance | 24.2 percentage of days | Standard Deviation 19.1 |