A Study to Evaluate the Effect of Advagraf Conversion From Prograf in Liver Transplant Subjects

NCT ID: NCT01882322

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-30
• Study Completion Date: 2017-01-03

Brief Summary

The objective of this study is to compare the efficacy and safety between a group that has been on Prograf twice daily therapy but converted to Advagraf once daily therapy and a group that maintained Prograf twice daily therapy.

Detailed Description

De novo Liver Transplant Recipients will be divided into two groups. Both groups will receive Prograf (Tacrolimus twice daily therapy), and at Month 1 (Week 4) after surgery, Prograf will be converted to Advagraf (modified release Tacrolimus, once daily) in one group, while Prograf therapy will be continued in other group.

Conditions

de Novo Liver Transplant Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Advagraf conversion group

Oral

Group Type: EXPERIMENTAL

Prograf

Intervention Type: DRUG

oral

Advagraf

Intervention Type: DRUG

oral

Prograf maintenance group

Oral

Group Type: ACTIVE_COMPARATOR

Prograf

Intervention Type: DRUG

oral

Interventions

Prograf

oral

Intervention Type: DRUG

Advagraf

oral

Intervention Type: DRUG

Other Intervention Names

Tacrolimus; modified release Tacrolimus

Eligibility Criteria

Inclusion Criteria

• A subject scheduled for liver transplantation from a living donor or brain dead
• In case of a woman of childbearing potential, a subject with a negative pregnancy test prior to enrollment and who consents to and would practice double contraception throughout the study (Pessary therapy, or rhythm method, or sexual abstinence, surgical sterilization, menopause or otherwise sterile; however, oral contraceptives are excluded.)
• A subject with terminal hepatic failure for which liver transplant is necessary
• A subject who understands and is completely aware of the study objective and risks and who submitted a written informed consent form on study participation

Exclusion Criteria

• A subject who received multiple organ transplants or any previous organ transplant (including re-transplantation of the liver)
• A subject who had received auxiliary transplant or used the bioartificial liver (cellular system)
• A subject allergic or resistant to macrolide antibiotics or Tacrolimus
• A subject who was taking Cyclosporine and Bosentan (Tracleer) that may interact with Tacrolimus, or potassium-sparing diuretics known to possibly cause hyperkalemia (Spironolactone, Triamterene) at screening
• A subject who requires immunosuppressive treatment or systemic chemotherapy from before transplant. However, a subject who received immunosuppressive treatment for less than 1 month prior to transplant to treat underlying hepatic disorder may be enrolled in the study if treatment is discontinued at the time of transplant.
• A subject with malignancy or malignant tumor history within the past 5 years; however, a subject may be enrolled in this study in case of successfully cured for basal cell carcinoma or squamous cell carcinoma of the skin.
• A subject who suffers severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect Tacrolimus absorption (may be determined at the discretion of the investigator)
• A subject with any type of substance abuse, psychological disorder, or communication disorder at the discretion of the investigator
• A subject who is participating in another study or participated within 28 days of the study, or who had received IP or non-registered medication
• A subject who is pregnant or breastfeeding
• A subject (transplant recipient) and/or donor who are positive to HIV
• A subject who cannot comply with the protocol-planned routine visit schedule
• A subject who is not appropriate for study participation at the discretion of the investigator

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Korea, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Seoul, , South Korea

Countries

South Korea

Related Links

https://astellasclinicalstudyresults.com/study.aspx?ID=235

Link to results on the Astellas Clinical Study Results website

Other Identifiers

ADV-LT-01

Identifier Type: -

Identifier Source: org_study_id