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

NCT04237246 | Completed Phase 4

• 1 other identifier: B2014:070
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

liver

Outcome Measures

Primary Outcomes (1)

• Comparative Bioavailability of a Once Daily FK506Formulation (Advagraf) in First Nations and Caucasian Patients with Stable Liver Transplants

  pharmacokinetics

  1 year

Study Arms (1)

Once daily Tacrolimus (Advegraf)

EXPERIMENTAL

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

24 hour "long acting" advegraf

Also known as: Advegraf

Once daily Tacrolimus (Advegraf)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

John Buhler Research Centre Health Sciences Centre

Winnipeg, Manitoba, R2K0a2, Canada

Location

MeSH Terms

Conditions

Liver Failure

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: January 23, 2020
• Study Start: April 1, 2015
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: January 23, 2020

Record last verified: 2015-04

Locations

CA (1)