A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients
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|ClinicalTrials.gov Identifier: NCT00384202|
Recruitment Status : Completed
First Posted : October 5, 2006
Last Update Posted : July 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Transplantation||Drug: Tacrolimus||Phase 3|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Other Name: Advagraf, FK506E, MR4
- Creatinine clearance [ Time Frame: 12 weeks ]
- Blood pressure, HbA1c, Acute rejection episodes [ Time Frame: 12 weeks ]
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 ClinicalTrials.gov 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|
|Birmingham, United Kingdom, B15 2TH|
|Study Director:||Use Central Contact||Astellas Pharma GmbH|