Status:
COMPLETED
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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® ba...
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-Treatm...
Eligibility Criteria
Inclusion
- 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
- Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00384202
Start Date
October 1 2006
End Date
November 1 2007
Last Update
July 9 2014
Active Locations (13)
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1
Lyon, France, 69437
2
Strasbourg, France, 67098
3
Villejuif, France, 94801
4
Berlin, Germany, 13353