A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.

An Open Label Study to Evaluate the Effect of CellCept in Combination With Cyclosporine A and Steroids on Renal Function and the Prevention of Acute Rejection in Heart Transplant Patients.

This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and steroids, in patients receiving a heart transplant. The anticipated time on study treatment is 24 weeks.

Inclusion Criteria:

• adult patients, >=18 years of age;
• patients receiving their first heart transplant (single organ transplant).

Exclusion Criteria:

• patients with a positive donor-specific cross-match at the time of transplantation;
• patients with any antibody-treated acute rejection;
• known contraindications to treatment with sirolimus;
• history of malignancy, other than excised non-melanoma skin cancer which has not recurred for 2 years.