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Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

NCT03527238 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2021-12-10

Study results available
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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.

Conditions

  • Liver Transplant
  • Kidney Transplant

Interventions

OTHER

PPM-based Computation Assisted Drug Dosing

Tacrolimus dosing based on application of PPM.

DRUG

Tacrolimus

Dosing of calcineurin inhibitor, tacrolimus

Sponsors & Collaborators

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

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Ali Zarrinpar, MD PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2020-06-02
Completion
2021-08-31
FDA Drug
Yes

Countries

  • United States
  • Singapore

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03527238 on ClinicalTrials.gov