Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

Tacrolimus and Mycophenolate Mofetil vs Tacrolimus and Sirolimus in SPK, Pancreas After Kidney or Pancreas Transplant Alone

This study was designed to determine which maintenance immunosuppressive agent, rapamycin or mycophenalate mofetil, resulted in better outcome in patients with type 1 diabetes and renal failure, who presented for a kidney-pancreas transplant.

This is a randomized, prospective single center study evaluating the two maintenance drugs above.

Inclusion Criteria:

• Patient with Type 1 diabetes and end stage renal disease.
• Women of childbearing potential must have had a negative pregnancy test (serum or urine).
• Patient agrees to participate in the study and sign an informed consent.
• Patient has no known contraindication to the administration of rapamycin or mycophenolate mofetil.
• Patient has no history of hypersensitivity to rapamycin or mycophenolate mofetil.

Exclusion Criteria:

• Patient has history of a malignancy within two years, with the exception of adequately treated localized squamous or basal cell carcinoma of the skin without evidence of recurrence.
• Patient is currently abusing drugs or alcohol.
• Patient is known or suspected to have an active infection or be seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) or human immunodeficiency virus (HIV).