Overview

A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients

Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
0
Participant gender:
All
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® based immunosuppressive regimen.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astellas Pharma Inc
Treatments:
Immunosuppressive Agents
Tacrolimus
Criteria
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.