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

NCT01882322 | Completed Phase 4

• 1 other identifier: ADV-LT-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

de Novo Liver Transplant Subjects

Keywords

FK506; tacrolimus; immunosuppressant

Outcome Measures

Primary Outcomes (1)

• Incidence of biopsy-confirmed acute rejection

  Acute rejection incidence (%) = Number of subjects with at least one biopsy -confirmed acute rejection / Total number of subjects included in the relevant analysis set \* 100

  from Week 4 to Week 24 post-transplant

Secondary Outcomes (4)

• Incidence of biopsy-confirmed acute rejection

  from Week 4 to Week 12 or Week 24

• Severity of biopsy-confirmed acute rejection

  from Week 4 to Week 12 and Week 24 after liver transplant

• Subject survival rate and graft survival rate

  from Week 4 to Week 12 and Week 24 after liver transplant

• Safety assessed by the incidence of adverse events, vital signs, physical exam. and labo-tests

  for 24 weeks after liver transplant

Study Arms (2)

Advagraf conversion group

EXPERIMENTAL

Oral

Drug: Prograf; Drug: Advagraf

Prograf maintenance group

ACTIVE COMPARATOR

Oral

Drug: Prograf

Interventions

Prograf DRUG

oral

Also known as: Tacrolimus

Advagraf conversion group; Prograf maintenance group

Advagraf DRUG

oral

Also known as: modified release Tacrolimus

Advagraf conversion group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 20, 2013
• Study Start: January 30, 2013
• Primary Completion: January 3, 2017
• Study Completion: January 3, 2017
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)