NCT00295594

Brief Summary

To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
627

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2005

Geographic Reach
11 countries

41 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 26, 2014

Status Verified

August 1, 2014

Enrollment Period

2.3 years

First QC Date

February 22, 2006

Last Update Submit

August 25, 2014

Conditions

Liver Transplantation

Keywords

TacrolimusLiver TransplantationTreatment OutcomeImmunosuppression

Outcome Measures

Primary Outcomes (1)

  • Incidence of and time to first biopsy proven acute rejection which requires treatment within 3 months following transplantation

    3 months

Secondary Outcomes (1)

  • Acute rejection. Incidence of and time to first acute rejection. Incidence of and time to first corticosteroid-resistant acute rejection.

    3 months

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: tacrolimus

2

EXPERIMENTAL
Drug: tacrolimus

Interventions

tacrolimusDRUG

Immunosuppression

Also known as: Prograf, FK506
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years of age or older who will undergo primary orthotopic liver or split liver allograft transplantation are eligible for the study. Patients receiving a liver transplant from cadaveric heart-beating donor with compatible AB0 blood type can be included.

You may not qualify if:

  • Recipient of an auxiliary graft
  • Patient is requiring initial sequential or parallel therapy with other immunosuppressive antibody preparation(s).
  • Patient is requiring ongoing dosing with corticosteroids.
  • Patient is exhibiting symptoms of, or is having any previous history of neoplastic disease
  • Patient or donor is known to be HIV positive.
  • Patient is allergic or intolerant to study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Unknown Facility

Ghent, 9000, Belgium

Location

Unknown Facility

Leuven, 3000, Belgium

Location

Unknown Facility

Liège, Belgium

Location

Unknown Facility

Copenhagen, Denmark

Location

Unknown Facility

Helsinki, 00130, Finland

Location

Unknown Facility

Bonn, 53105, Germany

Location

Unknown Facility

Erlangen, 91054, Germany

Location

Unknown Facility

Essen, 45122, Germany

Location

Unknown Facility

Hamburg, 20251, Germany

Location

Unknown Facility

Hanover, 30625, Germany

Location

Unknown Facility

Kiel, 24105, Germany

Location

Unknown Facility

Mainz, 55131, Germany

Location

Unknown Facility

Budapest, 1082, Hungary

Location

Unknown Facility

Bari, 70124, Italy

Location

Unknown Facility

Bergamo, 24128, Italy

Location

Unknown Facility

Milan, 20122, Italy

Location

Unknown Facility

Milan, 20162, Italy

Location

Unknown Facility

Napoli, 80131, Italy

Location

Unknown Facility

Padua, 35128, Italy

Location

Unknown Facility

Palermo, 90134, Italy

Location

Unknown Facility

Udine, 33100, Italy

Location

Unknown Facility

Szczecin, 71-455, Poland

Location

Unknown Facility

Wroclaw, 50-326, Poland

Location

Unknown Facility

A Coruña, 15006, Spain

Location

Unknown Facility

Barcelona, 08035, Spain

Location

Unknown Facility

Córdoba, 14004, Spain

Location

Unknown Facility

Granada, 18012, Spain

Location

Unknown Facility

Madrid, 28007, Spain

Location

Unknown Facility

Madrid, 28034, Spain

Location

Unknown Facility

Madrid, 28035, Spain

Location

Unknown Facility

Murcia, 30120, Spain

Location

Unknown Facility

Pamplona, 31008, Spain

Location

Unknown Facility

Santiago, 15706, Spain

Location

Unknown Facility

Seville, 41013, Spain

Location

Unknown Facility

Valencia, 46009, Spain

Location

Unknown Facility

Gothenburg, 41345, Sweden

Location

Unknown Facility

Uppsala, 75105, Sweden

Location

Unknown Facility

Bern, 3010, Switzerland

Location

Unknown Facility

Zurich, 8091, Switzerland

Location

Unknown Facility

Leeds, United Kingdom

Location

Unknown Facility

Newcastle, United Kingdom

Location

Related Links

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Medical Physician

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2006

First Posted

February 24, 2006

Study Start

March 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

August 26, 2014

Record last verified: 2014-08

Locations

IT(8)SE(2)BE(3)DK(1)FI(1)ES(12)CH(2)HU(1)DE(7)GB(2)PL(2)