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Comparative FK506 Drug Levels of Once Daily Advagraf in First Nations and Caucasian Patients With Liver Transplants

NCT04237246 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-01-23

No results posted yet for this study

Summary

Background:

Previous studies have documented differences in the pharmacokinetics (PK) of a once daily FK506 formulation (Advagraf) based on patient ethnicity. These findings may be of particular relevance to the First Nations population who constitute a large and increasing segment of the liver transplant population in Canada.

Aim:

The purpose of the present study is to determine whether PK differences exist for Advagraf in First Nations compared to Caucasian liver transplant patients.

Objectives:

1. Document and compare PK determinations for Advagraf in First Nations and Caucasian patients with stable liver transplants.
2. Document and compare CYP3A gene expression profiles in the two ethnic populations.

Study Design:

* single-centre, open-label
* consecutive enrollment (N=8/group)
* self-identified adult First Nations and Caucasian ethnic cohorts
* 7 day steady state conversion (mg/mg/day) from twice to once daily FK506 formulation
* timed blood samples at 0, 1.5, 2, 4, 6, and 24 hours post medication
* PK determinations:concentration at zero time (C0), time to maximum concentration (Tmax),Area Under the Curve (AUC 0-24), apparent oral clearance (CLoral) and maximum concentration (Cmax)

Methods:

* whole blood FK506 levels will be measured by UPLC tandem mass spectroscopy
* CYP3A allele analyses will be performed by Dr. Richard Kim, University of Western Ontario

Relevance:

The results of this study will serve to determine whether present guidelines for conversion of twice to once daily FK506 formulations need be modified for First Nations liver transplant patients.

Conditions

  • Liver Failure

Interventions

DRUG

Tacrolimus

24 hour "long acting" advegraf

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-11-27
Completion
2019-11-27

Countries

  • Canada

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 NCT04237246 on ClinicalTrials.gov