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

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ClinicalTrials.gov Identifier: NCT03527238
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : December 25, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Liver Transplant Kidney Transplant Other: PPM-based Computation Assisted Drug Dosing Drug: Tacrolimus Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine
Actual Study Start Date : September 21, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Active Comparator: Standard of Care
Standard of Care Tacrolimus Drug Dosing
Drug: Tacrolimus
Dosing of calcineurin inhibitor, tacrolimus

Experimental: Phenotypic Precision Medicine (PPM)
PPM-based Computation Assisted Drug Dosing
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




Primary Outcome Measures :
  1. Tacrolimus Target Trough Level Maintenance [ Time Frame: 2 weeks ]
    Days within Tacrolimus Target Trough Level



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults undergoing liver and/or kidney transplantation

Exclusion Criteria:

  • transplant patients with contraindications to tacrolimus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527238


Contacts
Contact: Ali Zarrinpar 3522650606 Ali.Zarrinpar@surgery.ufl.edu

Locations
United States, California
UCLA Active, not recruiting
Los Angeles, California, United States, 90095
United States, Florida
UF Health at the University of Florida Recruiting
Gainesville, Florida, United States, 32610
Singapore
National University of Singapore Active, not recruiting
Singapore, Singapore, 119077
Sponsors and Collaborators
University of Florida
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Ali Zarrinpar, MD PhD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03527238     History of Changes
Other Study ID Numbers: IRB201800053 -N -A
1R21DK116140-01 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Phenotypic Precision Medicine (PPM)
Tacrolimus
Calcineurin Inhibitors

Additional relevant MeSH terms:
Tacrolimus
Calcineurin Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action