Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Canada, Inc.
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Tacrolimus

Criteria

Inclusion Criteria:

• Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.

• Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.

• Subject is 18 years of age or over at the time of transplant.

• If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion Criteria:

• Recipients of a kidney from a donor 60 years of age or older

• Recipients of donation after cardiac death (DCD) donors

• Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)

• Subjects with a second renal allograft who had their original graft for < 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure

• Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) >20

• Subjects with hepatitis B & C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)

• Subjects receiving an allograft with cold ischemia time 24 hours or greater

• Subjects who have received an investigational drug within three months prior to randomization

• Subjects who are breastfeeding

• Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients

• Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or adherence to the protocol