Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
Graft Rejection, Kidney Failure
About this trial
This is an interventional prevention trial for Graft Rejection focused on measuring Heart Transplant, Kidney Failure
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
1
2
Group 1: Continuation of CNI regimen
Group 2: (CNI-Free) Conversion to SRL-based regimen