NCT00384202

Brief Summary

Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_3

Geographic Reach
6 countries

13 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

October 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

1.1 years

First QC Date

October 4, 2006

Last Update Submit

July 7, 2014

Conditions

Transplantation

Keywords

TacrolimusLiver Transplantation

Outcome Measures

Primary Outcomes (1)

  • Creatinine clearance

    12 weeks

Secondary Outcomes (1)

  • Blood pressure, HbA1c, Acute rejection episodes

    12 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: Tacrolimus

Interventions

TacrolimusDRUG

Immunosuppression

Also known as: Advagraf, FK506E, MR4
1

Eligibility Criteria

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

You may qualify if:

  • Liver transplant at least 12 months prior to enrollment.
  • Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrollment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL.

You may not qualify if:

  • Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Lyon, 69437, France

Location

Unknown Facility

Strasbourg, 67098, France

Location

Unknown Facility

Villejuif, 94801, France

Location

Unknown Facility

Berlin, 13353, Germany

Location

Unknown Facility

Hamburg, 20251, Germany

Location

Unknown Facility

Dublin, Dublin 4, Ireland

Location

Unknown Facility

Warsaw, 02-005, Poland

Location

Unknown Facility

Barakaldo, 48903, Spain

Location

Unknown Facility

Barcelona, 08035, Spain

Location

Unknown Facility

Santiago de Compostela, 15706, Spain

Location

Unknown Facility

Seville, 41013, Spain

Location

Unknown Facility

Valencia, 46009, Spain

Location

Unknown Facility

Birmingham, B15 2TH, United Kingdom

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Use Central Contact

    Astellas Pharma GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 5, 2006

Study Start

October 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations

FR(3)IE(1)PL(1)GB(1)DE(2)ES(5)