A Study of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant

A Prospective, Multi-center, Open-labeled, Randomized Clinical Trial of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant Recipients to Compare QD Early Conversion and BID Tacrolimus Formulation.

A study of patient adherence and convenience to immunosuppressive agents in newly liver transplant recipients - a prospective, multi-center, open-labeled, randomized clinical trial for comparison between once-daily early conversion and twice-daily tacrolimus formulation.

Study Overview

• Status: Recruiting
• Conditions: Liver Transplantation
• Intervention / Treatment: Drug: Advagraf; Drug: Prograf

Detailed Description

This is prospective, multi-center, open-labeled, randomized study to investigate adherence of administration of once-daily tacrolimus formulation (Advagraf®) in newly Taiwanese (Chinese) liver transplant patients. The procedure of liver transplantation will follow the site-specific procedure. Each subject will be randomized on postoperative day 15 (POD15; defined Day 14 +/- 1)

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wei-Chen Lee; Phone Number: 09753-68195; Email: weichen@cgmh.org.tw

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Wei-Chen Lee; Phone Number: 3631 03-3281200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient has been fully informed and has signed an IRB approved informed consent form within 7 days (Day 7-13) prior to POD 15 and is willing and able to follow study procedure
• Patient is a primary liver transplant recipient
• Patient is 20 to 70 years of age
• Patient should be clearly conscious, fully understand and able to answer questionnaire

Exclusion Criteria:

• Patient has previously received or is receiving an organ transplant other than a liver.
• Patient currently requires dialysis
• Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
• Patient has received a liver transplant from a non-heart beating donor
• Patient who is HCV negative has received an HCV positive (HCV RNA by PCR or HCV antibody) donor liver
• Patient who is HbsAg negative has received an HbsAg positive (HBV DNA by PCR or HBV antibody) donor liver
• Patient has received a liver transplant from a decrease donor > 70 years of age
• Patient has a current malignancy or a history of malignancy (within the past 5 years), except hepatocellular carcinoma within UCSF Criteria and basal or non-metastatic squamous cell carcinoma of skin that has been treated successfully.
• Patient is hemodynamically unstable on POD 15

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; Switch from Prograf to Advagraf on POD 15	Drug: Advagraf; Tacrolimus prolonged-release hard capsules (QD)
Active Comparator: Control Arm; Continue Prograf treatment	Drug: Prograf; Tacolimus capsules (q12h)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence of administration of Advagraf in newly Taiwanese (Chinese) liver transplant patients.	• The adherence of enrolled 150 subjects will be assessed by the Basel assessment of adherence to immunosuppressive medications scale (BAASIS)	Visit 1 (Day 14) to Visit 6 (Day 364) - 50 weeks observation

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Astellas Pharma Taiwan, Inc.
• Investigators: Principal Investigator: Wei-Chen Lee, CGMH

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2017
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): September 30, 2025

Study Registration Dates

• First Submitted: July 10, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (Actual): July 13, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: adherence; prograf; conversion; advagraf
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: 201600495A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No