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

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: NCT04237246
Recruitment Status : Completed
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
University of Manitoba

Brief 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.


Condition or disease Intervention/treatment Phase
Liver Failure Drug: Tacrolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative FK506 Drug Levels of Once Daily Advagraf in First Nations and Caucasian Patients With Liver Transplants
Study Start Date : April 2015
Actual Primary Completion Date : November 27, 2019
Actual Study Completion Date : November 27, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Once daily Tacrolimus (Advegraf) Drug: Tacrolimus
24 hour "long acting" advegraf
Other Name: Advegraf




Primary Outcome Measures :
  1. Comparative Bioavailability of a Once Daily FK506Formulation (Advagraf) in First Nations and Caucasian Patients with Stable Liver Transplants [ Time Frame: 1 year ]
    pharmacokinetics



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First Nations or Caucasian subjects between the ages of 18 and 70 years.
  • A minimum of 12 months from the transplant procedure.
  • No acute rejection episode within the previous 3 months.
  • No evidence of pre-transplant liver disease recurrence
  • Stable Tacrolimus dosage during the previous 3 months.

Exclusion Criteria:

  • Patients with absorption problems or unable to take oral medications.
  • Patients who are on steroids
  • Patients unable or unwilling to provide informed consent.

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): NCT04237246


Locations
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Canada, Manitoba
John Buhler Research Centre Health Sciences Centre
Winnipeg, Manitoba, Canada, R2K0a2
Sponsors and Collaborators
University of Manitoba
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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT04237246    
Other Study ID Numbers: B2014:070
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: April 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Manitoba:
liver
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action