A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- Creatinine clearance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Blood pressure, HbA1c, Acute rejection episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
Other Name: Advagraf, FK506E, MR4
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.
|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|
|Birmingham, United Kingdom, B15 2TH|
|Study Director:||Use Central Contact||Astellas Pharma GmbH|