Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study was to determine if rapid discontinuation of corticosteroids (also known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus) and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin) will give similar safety and efficacy results compared to continuation of corticosteroids (also known as prednisone maintenance) and standard maintenance immunosuppression with Prograf (tacrolimus), CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin).

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

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Antilymphocyte Serum; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

• First time kidney transplant recipients who receives a kidney from a cadaveric, living related or living unrelated donor

• Age greater than 18 years and less than 75 years

• Caucasian recipients

• Patients with current low panel reactive antibody (PRA) levels (<10%)

• Patients with signed and dated informed consent

• Women of childbearing potential must have a negative pregnancy test at baseline and agree to use a medically acceptable method of contraception throughout the treatment period.

Exclusion Criteria:

• Other than Caucasian ethnicity

• Patients with HIV+ or

• Patients with HbsAg+ or Hepatitis C positive

• Patients with a history of malignancy in the past 5 years

• Patients with active systemic or localized major infection

• Patients with a history of chronic steroid use for other diseases