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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00693524
First received: June 4, 2008
Last updated: July 9, 2008
Last verified: July 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall frequences of acute rejection episodes [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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
oral
Other Names:
  • FK506
  • Prograf
Drug: Anti-IL2R AB
i.v.
Other Name: daclizumab
Drug: Mycophenolate mofetil
oral
Active Comparator: 2
Tacrolimus + Steroid
Drug: tacrolimus
oral
Other Names:
  • FK506
  • Prograf
Drug: prednisone
oral
Other Name: steroid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00693524

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

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00693524     History of Changes
Other Study ID Numbers: FG-506-01-IT-01
Study First Received: June 4, 2008
Last Updated: July 9, 2008
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Interleukin-2
Mycophenolic Acid
Prednisone
Mycophenolate mofetil
Tacrolimus
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Immunosuppressive Agents
Immunologic Factors
Antibiotics, Antineoplastic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 28, 2014