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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 4, 2018
First Posted Date  ICMJE May 17, 2018
Results First Submitted Date  ICMJE November 12, 2021
Results First Posted Date  ICMJE December 10, 2021
Last Update Posted Date December 10, 2021
Actual Study Start Date  ICMJE September 21, 2018
Actual Primary Completion Date June 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2021)
Tacrolimus Target Trough Level Maintenance [ Time Frame: 2 weeks ]
Percentage of Days Far (> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
Tacrolimus Target Trough Level Maintenance [ Time Frame: 2 weeks ]
Days within Tacrolimus Target Trough Level
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine
Official Title  ICMJE Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Liver Transplant
  • Kidney Transplant
Intervention  ICMJE
  • Other: PPM-based Computation Assisted Drug Dosing
    Tacrolimus dosing based on application of PPM.
    Other Name: Computation based dosing
  • Drug: Tacrolimus
    Dosing of calcineurin inhibitor, tacrolimus
Study Arms  ICMJE
  • Active Comparator: Standard of Care
    Standard of Care Tacrolimus Drug Dosing
    Intervention: Drug: Tacrolimus
  • Experimental: Phenotypic Precision Medicine (PPM)
    PPM-based Computation Assisted Drug Dosing
    Interventions:
    • Other: PPM-based Computation Assisted Drug Dosing
    • Drug: Tacrolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2021)
62
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2018)
75
Actual Study Completion Date  ICMJE August 31, 2021
Actual Primary Completion Date June 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adults undergoing liver and/or kidney transplantation

Exclusion Criteria:

  • transplant patients with contraindications to tacrolimus
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03527238
Other Study ID Numbers  ICMJE IRB201800053 -N -A
1R21DK116140-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Ali Zarrinpar, MD PhD University of Florida
PRS Account University of Florida
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP