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Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

NCT ID: NCT03527238

Last Updated: 2021-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-21

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Liver Transplant Kidney Transplant

Keywords

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Phenotypic Precision Medicine (PPM) Tacrolimus Calcineurin Inhibitors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard of Care

Standard of Care Tacrolimus Drug Dosing

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

Dosing of calcineurin inhibitor, tacrolimus

Phenotypic Precision Medicine (PPM)

PPM-based Computation Assisted Drug Dosing

Group Type EXPERIMENTAL

PPM-based Computation Assisted Drug Dosing

Intervention Type OTHER

Tacrolimus dosing based on application of PPM.

Tacrolimus

Intervention Type DRUG

Dosing of calcineurin inhibitor, tacrolimus

Interventions

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PPM-based Computation Assisted Drug Dosing

Tacrolimus dosing based on application of PPM.

Intervention Type OTHER

Tacrolimus

Dosing of calcineurin inhibitor, tacrolimus

Intervention Type DRUG

Other Intervention Names

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Computation based dosing

Eligibility Criteria

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Inclusion Criteria

* adults undergoing liver and/or kidney transplantation

Exclusion Criteria

* transplant patients with contraindications to tacrolimus
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali Zarrinpar, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UCLA

Los Angeles, California, United States

Site Status

UF Health at the University of Florida

Gainesville, Florida, United States

Site Status

National University of Singapore

Singapore, , Singapore

Site Status

Countries

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United States Singapore

References

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Khong J, Lee M, Warren C, Kim UB, Duarte S, Andreoni KA, Shrestha S, Johnson MW, Battula NR, McKimmy DM, Beduschi T, Lee JH, Li DM, Ho CM, Zarrinpar A. Tacrolimus dosing in liver transplant recipients using phenotypic personalized medicine: A phase 2 randomized clinical trial. Nat Commun. 2025 May 16;16(1):4558. doi: 10.1038/s41467-025-59739-6.

Reference Type DERIVED
PMID: 40379675 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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1R21DK116140-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201800053 -N -A

Identifier Type: -

Identifier Source: org_study_id