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

Astellas

Status and phase: Completed; Phase 4

Conditions: de Novo Liver Transplant Subjects

Treatments: Drug: Advagraf; Drug: Prograf

Study type: Interventional

Funder types: Industry

Identifiers

NCT01882322

ADV-LT-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Advagraf conversion group

Experimental group

Description:

Oral

Treatment:

Drug: Prograf

Drug: Advagraf

Prograf maintenance group

Active Comparator group

Description:

Oral

Treatment:

Drug: Prograf