Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-emulsion

A Prospective, Randomized, Open-label, Twenty-six Week Study of the Efficacy and Safety of Converting Kidney and Liver Transplant Recipients With Tacrolimus-associated Abnormal Glucose Metabolism to Cyclosporine Micro-emulsion With C2 Monitoring

New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.

Inclusion Criteria:

• Recipients of first or second cadaveric or living donor kidney transplantation or first cadaveric or living donor liver transplantation
• Receiving tacrolimus as a primary immunosuppressant
• Currently on any diabetic agent or meets the American Diabetes Association definition of diabetes mellitus

Exclusion Criteria:

• History of treated diabetes mellitus prior to transplantation
• Less than 2 weeks post-transplantation for kidney and less than 8 weeks for liver
• Greater than 36 months post-transplantation
• Onset of diabetes is greater than 12 months prior to time of study entry
• Has unacceptable or unstable graft function

Other protocol-defined inclusion/exclusion criteria may apply.