A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00384202
Recruitment Status : Completed
First Posted : October 5, 2006
Last Update Posted : July 9, 2014
Information provided by:
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Transplantation Drug: Tacrolimus Phase 3

Detailed Description:

Multicenter, open, single sequence crossover study. Subject Enrolment: Prograf® administered twice daily is replaced by Prograf as study medication, administered twice daily.

Six weeks Prograf-Treatment Phase to confirm compliance to regimen stability requirements (see Inclusion and Exclusion Criteria), and collection of data under Prograf treatment.

Conversion from Prograf (twice daily, morning & evening dosing) total daily dose to MR4 once daily (only morning dosing) on a 1:1 (mg:mg) basis on Day 1.

Twelve weeks MR4-Treatment Phase with study assessments for safety and efficacy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open, Single Sequence Crossover Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Stable Liver Transplant Patients Converted From a Prograf® Based Immunosuppressive Regimen
Study Start Date : October 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Tacrolimus
Other Name: Advagraf, FK506E, MR4

Primary Outcome Measures :
  1. Creatinine clearance [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Blood pressure, HbA1c, Acute rejection episodes [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00384202

Lyon, France, 69437
Strasbourg, France, 67098
Villejuif, France, 94801
Berlin, Germany, 13353
Hamburg, Germany, 20251
Dublin, Ireland, Dublin 4
Warszawa, Poland, 02-005
Barakaldo, Spain, 48903
Barcelona, Spain, 08035
Santiago de Compostela, Spain, 15706
Sevilla, Spain, 41013
Valencia, Spain, 46009
United Kingdom
Birmingham, United Kingdom, B15 2TH
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma GmbH

Additional Information:
Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV Identifier: NCT00384202     History of Changes
Other Study ID Numbers: PMR-EC-1105
First Posted: October 5, 2006    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014

Keywords provided by Astellas Pharma Inc:
Liver Transplantation

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action