Clinical trial NCT03216447: A Study of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Liver Transplantation
Keywords: adherence
conversion
advagraf
prograf
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Taiwan, Inc.
First posted: 2017-07-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Adherence of administration of Advagraf in newly Taiwanese (Chinese) liver transplant patients.
timeFrame: Visit 1 (Day 14) to Visit 6 (Day 364) - 50 weeks observation
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: CGMH
name: Wei-Chen Lee
role: PRINCIPAL_INVESTIGATOR
References: