A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients

NCT01018914 | Completed Phase 4

• 1 other identifier: ADVLTx-0901-TW
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief Summary

To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.

Conditions

Liver Transplantation

Keywords

Prograf; Advagraf; Myfortic

Outcome Measures

Primary Outcomes (1)

• Incidence of biopsy confirmed acute rejection

  during the 6 months post-transplant.

Secondary Outcomes (4)

• Patient and graft survival rates

  during the 6 months post-transplant

• Time to first biopsy confirmed acute rejection episode

  during the 6 months post-transplant

• Incidence of anti-lymphocyte antibody therapy for treatment of rejection

  during the 6 months post-transplant.

• Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs

  throughout the study

Study Arms (2)

Prograf with Myfortic

ACTIVE COMPARATOR

Drug: Prograf; Drug: Myfortic

Advagraf with Myfortic

EXPERIMENTAL

Drug: Advagraf; Drug: Myfortic

Interventions

Prograf DRUG

oral

Also known as: Tacrolimus, FK506

Prograf with Myfortic

Advagraf DRUG

oral

Also known as: Extended release tacrolimus, FK506E, MR4

Advagraf with Myfortic

Myfortic DRUG

oral

Also known as: Mycophenolate sodium

Advagraf with Myfortic; Prograf with Myfortic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is a primary liver transplant recipient
• Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant
• Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
• Patient must receive 1st dose of study drug within 24 hours of pre-transplantation

You may not qualify if:

• Patient has previously received or is receiving an organ transplant other than a liver
• Patient currently requires dialysis
• Patient has received a liver transplant from a non-heart beating donor
• Patient has received an ABO incompatible donor liver
• Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
• Patient has fulminant hepatic failure, unless hemodynamically stable
• Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives
• Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
• Patient has a known hypersensitivity to tacrolimus, enteric-coated mycophenolate sodium or corticosteroids
• Patient is pregnant or lactating

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Taiwan, Inc.: collaborator

Study Sites (3)

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Related Links

• Link to results on Astellas Clinical Study Results Web site

MeSH Terms

Interventions

Tacrolimus; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

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: November 23, 2009
• First Posted: November 25, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

TW (3)