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

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00693524

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 II

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Prednisone Tacrolimus Immunoglobulins Globulin, Immune Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Tacrolimus anhydrous Dacliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

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
1: Experimental Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil	Drug: tacrolimus oral Drug: Anti-IL2R AB i.v. Drug: Mycophenolate mofetil oral
2: Active Comparator Tacrolimus + Steroid	Drug: tacrolimus oral Drug: prednisone oral

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693524

Locations

Italy

Bologna, Italy

Padova, Italy

Udine, Italy

Milano, Italy

Torino, Italy

Napoli, Italy

Roma, Italy

Genova, Italy

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma Europe BV

More Information

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

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

Keywords provided by Astellas Pharma Inc:

liver allograft transplantation
sequential therapy
tacrolimus

Study placed in the following topic categories:

Prednisone
Antibodies
Daclizumab
Mycophenolic Acid

Mycophenolate mofetil
Tacrolimus
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Enzyme Inhibitors
Antibiotics, Antineoplastic
Glucocorticoids
Hormones
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009