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Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine (PPM - Pro)

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ClinicalTrials.gov Identifier: NCT03527238
Recruitment Status : Completed
First Posted : May 17, 2018
Results First Posted : December 10, 2021
Last Update Posted : December 10, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Conditions Liver Transplant
Kidney Transplant
Interventions Other: PPM-based Computation Assisted Drug Dosing
Drug: Tacrolimus
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard of Care Phenotypic Precision Medicine (PPM)
Hide Arm/Group Description

Standard of Care Tacrolimus Drug Dosing

Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus

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

Period Title: Overall Study
Started 31 31
Completed 29 27
Not Completed 2 4
Arm/Group Title Standard of Care Phenotypic Precision Medicine (PPM) Total
Hide Arm/Group Description

Standard of Care Tacrolimus Drug Dosing

Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus

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 of all reporting groups
Overall Number of Baseline Participants 31 31 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
  83.9%
25
  80.6%
51
  82.3%
>=65 years
5
  16.1%
6
  19.4%
11
  17.7%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 31 participants 31 participants 62 participants
57
(42 to 61)
58
(50 to 63)
57.5
(49.25 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
Female
14
  45.2%
13
  41.9%
27
  43.5%
Male
17
  54.8%
18
  58.1%
35
  56.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
Hispanic or Latino
2
   6.5%
4
  12.9%
6
   9.7%
Not Hispanic or Latino
29
  93.5%
27
  87.1%
56
  90.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   3.2%
1
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   6.5%
0
   0.0%
2
   3.2%
White
29
  93.5%
30
  96.8%
59
  95.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 31 participants 62 participants
31 31 62
1.Primary Outcome
Title Tacrolimus Target Trough Level Maintenance
Hide Description Percentage of Days Far (> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard of Care Phenotypic Precision Medicine (PPM)
Hide Arm/Group Description:

Standard of Care Tacrolimus Drug Dosing

Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus

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 Number of Participants Analyzed 29 27
Mean (Standard Deviation)
Unit of Measure: percentage of days
38.4  (27.4) 24.2  (19.1)
Time Frame 30 days after discharge
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard of Care Phenotypic Precision Medicine (PPM)
Hide Arm/Group Description

Standard of Care Tacrolimus Drug Dosing

Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus

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

All-Cause Mortality
Standard of Care Phenotypic Precision Medicine (PPM)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)      0/31 (0.00%)    
Hide Serious Adverse Events
Standard of Care Phenotypic Precision Medicine (PPM)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/31 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard of Care Phenotypic Precision Medicine (PPM)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/31 (19.35%)      6/31 (19.35%)    
Immune system disorders     
Rejection   6/31 (19.35%)  6 6/31 (19.35%)  6
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ali Zarrinpar
Organization: University of Florida
Phone: 352-265-0606
EMail: ali.zarrinpar@surgery.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03527238    
Other Study ID Numbers: IRB201800053 -N -A
1R21DK116140-01 ( U.S. NIH Grant/Contract )
First Submitted: May 4, 2018
First Posted: May 17, 2018
Results First Submitted: November 12, 2021
Results First Posted: December 10, 2021
Last Update Posted: December 10, 2021