Trial Outcomes & Findings for Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine (NCT NCT03527238)
NCT ID: NCT03527238
Last Updated: 2021-12-10
Results Overview
Percentage of Days Far (\> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
2 weeks
Results posted on
2021-12-10
Participant Flow
Participant milestones
| Measure |
Standard of Care
Standard of Care Tacrolimus Drug Dosing
Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine
Baseline characteristics by cohort
| Measure |
Standard of Care
n=31 Participants
Standard of Care Tacrolimus Drug Dosing
Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus
|
Phenotypic Precision Medicine (PPM)
n=31 Participants
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
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Age, Continuous
|
57 years
n=93 Participants
|
58 years
n=4 Participants
|
57.5 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=93 Participants
|
31 participants
n=4 Participants
|
62 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPercentage of Days Far (\> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level
Outcome measures
| Measure |
Standard of Care
n=29 Participants
Standard of Care Tacrolimus Drug Dosing
Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus
|
Phenotypic Precision Medicine (PPM)
n=27 Participants
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
|
|---|---|---|
|
Tacrolimus Target Trough Level Maintenance
|
38.4 percentage of days
Standard Deviation 27.4
|
24.2 percentage of days
Standard Deviation 19.1
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phenotypic Precision Medicine (PPM)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care
n=31 participants at risk
Standard of Care Tacrolimus Drug Dosing
Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus
|
Phenotypic Precision Medicine (PPM)
n=31 participants at risk
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
|
|---|---|---|
|
Immune system disorders
Rejection
|
19.4%
6/31 • Number of events 6 • 30 days after discharge
|
19.4%
6/31 • Number of events 6 • 30 days after discharge
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place