Overview

Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal

Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
0
Participant gender:
All
Summary
To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Cincinnati
Collaborator:
Novartis
Treatments:
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Criteria
Inclusion Criteria:

- Males and females between 18 and 75 years of age.

- Patients who are primary or repeat cadaveric, living unrelated or non-HLA identical
living related donor renal transplant recipients.

Exclusion Criteria:

- Patient previously received or is receiving an organ transplant other than kidney.

- Primary or re-transplant from human leukocyte antigen (HLA)-identical living donor.

- Recipient or donor is known to be seropositive for hepatitis C virus (HCV), hepatitis
B virus (HBV), or human immunodeficiency virus (HIV).

- Uncontrolled concomitant infection or other unstable medical condition.

- Patients that received an investigational drug in the 30 days prior to transplant.

- Known hypersensitivity to tacrolimus, mycophenolate mofetil (MMF), enteric-coated
mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.

- Receiving chronic steroid therapy at the time of transplant.

- History of malignancy in last 5 years.

- Pregnant or lactating.