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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03216447

Collaborator

Astellas Pharma Taiwan, Inc. (Industry)

150

Enrollment

Location

Arms

94.2

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplantation	Drug: Advagraf Drug: Prograf	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

open labeled

Primary Purpose:

Treatment

Official Title:

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.

Actual Study Start Date :

Nov 23, 2017

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Sep 30, 2025

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital	Taoyuan		Taiwan

Sponsors and Collaborators

Chang Gung Memorial Hospital
Astellas Pharma Taiwan, Inc.

Investigators

Principal Investigator: Wei-Chen Lee, CGMH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wei-Chen Lee, Professor, Chang Gung Memorial Hospital

ClinicalTrials.gov Identifier:

NCT03216447

Other Study ID Numbers:

201600495A3

First Posted:

Jul 13, 2017

Last Update Posted:

Jun 5, 2020

Last Verified:

Jun 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wei-Chen Lee, Professor, Chang Gung Memorial Hospital

Additional relevant MeSH terms:

Tacrolimus

Study Results

No Results Posted as of Jun 5, 2020