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

Chang Gung Medical Foundation

Status and phase: Enrolling; Phase 4

Conditions: Liver Transplantation

Treatments: Drug: Advagraf; Drug: Prograf

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03216447

201600495A3

Details and patient eligibility

About

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.

Full 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)

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Experimental Arm

Experimental group

Description:

Switch from Prograf to Advagraf on POD 15

Treatment:

Drug: Advagraf

Control Arm

Active Comparator group

Description:

Continue Prograf treatment

Treatment:

Drug: Prograf