This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Sequential Therapy (FK506 + Monoclonal Anti-IL2R Antibodies + MMF) Versus FK506 With Steroids in Liver TX (TAST)

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: June 4, 2008
Last updated: August 25, 2014
Last verified: August 2014
Study to evaluate the benefits and any risks of the delayed administration of tacrolimus in a combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab), in comparison with a standard steroid + tacrolimus double drug regimen

Condition Intervention Phase
Liver Transplantation Drug: tacrolimus Drug: Anti-IL2R AB Drug: Mycophenolate mofetil Drug: prednisone Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Randomized, Multicentre Clinical Study to Compare the Safety and Efficacy of a Combination of Sequential Therapy of Tacrolimus (FK506) With Monoclonal Anti-IL2R Antibodies and Mycophenolate Mofetil Versus Tacrolimus (FK506) With Steroids in Liver Allograft Transplantation

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of first acute rejection [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Overall frequences of acute rejection episodes [ Time Frame: 3 months ]

Enrollment: 94
Study Start Date: November 2002
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil
Drug: tacrolimus
Other Names:
  • FK506
  • Prograf
Drug: Anti-IL2R AB
Other Name: daclizumab
Drug: Mycophenolate mofetil
Active Comparator: 2
Tacrolimus + Steroid
Drug: tacrolimus
Other Names:
  • FK506
  • Prograf
Drug: prednisone
Other Name: steroid


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient is undergoing orthotopic liver allograft transplantation. This includes partial organ transplantation. Age of donor between 5 and 65 years

Exclusion Criteria:

  • Patient has previously received or is receiving an organ transplant (including liver re-transplantation)
  • Recipient of an auxiliary graft or in which a bio-artificial liver has been used
  • Patient is receiving a living related liver transplantation
  • Patient is requiring steroids as well as chemotherapy prior to transplantation
  • Patient having any previous history of neoplastic disease of any type (including leukaemia). However, patients with primary liver carcinoma can be included if they meet the following criteria:

    • > 3 nodes
    • No node larger than 5 cm
    • No metastases
    • No vascular invasion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00693524

Bologna, Italy
Genova, Italy
Milano, Italy
Napoli, Italy
Padova, Italy
Roma, Italy
Torino, Italy
Udine, Italy
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00693524     History of Changes
Other Study ID Numbers: FG-506-01-IT-01
Study First Received: June 4, 2008
Last Updated: August 25, 2014

Keywords provided by Astellas Pharma Inc:
liver allograft transplantation
sequential therapy

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic processed this record on September 21, 2017