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

NCT00693524 | Completed Phase 2

• 1 other identifier: FG-506-01-IT-01
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Liver Transplantation

Keywords

liver allograft transplantation; sequential therapy; tacrolimus

Outcome Measures

Primary Outcomes (1)

• Incidence of first acute rejection

  3 months

Secondary Outcomes (1)

• Overall frequences of acute rejection episodes

  3 months

Study Arms (2)

1

EXPERIMENTAL

Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil

Drug: tacrolimus; Drug: Anti-IL2R AB; Drug: Mycophenolate mofetil

2

ACTIVE COMPARATOR

Tacrolimus + Steroid

Drug: tacrolimus; Drug: prednisone

Interventions

tacrolimus DRUG

oral

Also known as: FK506, Prograf

1; 2

Anti-IL2R AB DRUG

i.v.

Also known as: daclizumab

1

Mycophenolate mofetil DRUG

oral

1

prednisone DRUG

oral

Also known as: steroid

2

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (8)

Unknown Facility

Bologna, Italy

Location

Unknown Facility

Genova, Italy

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Napoli, Italy

Location

Unknown Facility

Padua, Italy

Location

Unknown Facility

Roma, Italy

Location

Unknown Facility

Torino, Italy

Location

Unknown Facility

Udine, Italy

Location

MeSH Terms

Interventions

Tacrolimus; Daclizumab; Mycophenolic Acid; Prednisone; Steroids

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Pregnadienediols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Central Contact

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 9, 2008
• Study Start: November 1, 2002
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

IT (8)