Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients

• Graft Rejection
• Kidney Failure

• Drug: cyclosporine or tacrolimus
  
  Cyclosporine and tacrolimus are provided by the sites and dosed to achieve a target trough level determined by the investigator; therefore, form, dosage, and frequency are site and patient specific. Duration should be 52 weeks on-therapy.
  Other Name: Brand names for cyclosporine are Neoral®, Sandimmune®, and Gengraf®; brand names for tacrolimus are Prograf® and Adagraf?.
• Drug: sirolimus
  
  Oral (1 and 2 mg) tablets, dosing should be once daily to achieve a target trough level of 7- 15 ng/mL. Duration should be 52 weeks on-therapy.
  Other Name: Rapamune®

• Active Comparator: 1
  
  Group 1: Continuation of CNI regimen
  Intervention: Drug: cyclosporine or tacrolimus
• Experimental: 2
  
  Group 2: (CNI-Free) Conversion to SRL-based regimen
  Intervention: Drug: sirolimus

Inclusion Criteria:

• Cardiac transplant recipients age 18 years or older receiving cyclosporine or tacrolimus since the time of transplant.
• 12 months after cardiac transplantation but less than 96 months post-transplantation.

Exclusion Criteria:

• Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after kidney transplant recipients).
• Prior or current use of sirolimus or everolimus unless administration was part of a "CNI holiday" lasting no more than 10 days.
• History of acute rejection within the last 3 months, malignancy within the last 5 years (except for adequately treated basal cell or squamous cell carcinoma of the skin), and human immunodeficiency virus (HIV) patients.