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

October 4, 2006
October 5, 2006
July 9, 2014
October 2006
November 2007   (Final data collection date for primary outcome measure)
Creatinine clearance [ Time Frame: 12 weeks ]
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Complete list of historical versions of study NCT00384202 on Archive Site
Blood pressure, HbA1c, Acute rejection episodes [ Time Frame: 12 weeks ]
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A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients
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
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.

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.

Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Tacrolimus
Other Name: Advagraf, FK506E, MR4
Experimental: 1
Intervention: Drug: Tacrolimus
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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November 2007
November 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Ireland,   Poland,   Spain,   United Kingdom
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Disclosure Office Europe, Astellas Pharma Europe BV
Astellas Pharma Inc
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Study Director: Use Central Contact Astellas Pharma GmbH
Astellas Pharma Inc
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP