Status:
COMPLETED
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney 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 kidney transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® b...
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
- Kidney 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 :
July 1 2007
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00384137
Start Date
October 1 2006
End Date
July 1 2007
Last Update
July 9 2014
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Bicêtre, France, 94275
2
Freiburg im Breisgau, Germany, 79106
3
Regensburg, Germany, 93053
4
Maastricht, Netherlands, 6229