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.