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

• Status: Completed
• Trial end date: 2007-07-01
• 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 kidney 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:

• 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 Criteria:

• Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.