Study Title: A 24 Month Multi-Center Randomized, Open Label Study to Evaluate the Efficacy and Safety of Concentration Controlled Everolimus with Corticosteroids in Combination with Minimization or Elimination of Tacrolimus in de novo Liver Transplant Recipients Compared to Tacrolimus and Corticosteroids (IRB# 008-039)

Short Title: Novartis

Study Description: The purpose of this study is to test the safety and effectiveness of a newer drug, everolimus, that is being studied in liver transplant patients to prevent acute rejection.  This study will evaluate the combination of everolimus with low doses of tacrolimus, or everolimus with a decrease of tacrolimus until you eventually do not need to take it.  These regimens will be compared with a commonly used regimen of regular doses of tacrolimus.

Some of the criteria for patients to qualify for the study include:

• Ability and willingness to provide written informed consent and adhere to the study regimen.
• Recipients who are 18-70 of age of a primary liver transplant from a deceased  donor.

The following are some of the criteria which will exclude patients from the study:

• Patients who are recipients of multiple solid organ or islet cell tissue transplants, or have previously received an organ or tissue transplant
• Patients who have combined liver-kidney transplant
• Recipients of liver from a living donor, or of a split liver 

Location:
Baylor University Medical Center                                             
Roberts Building-4th Floor                             
Dallas, TX 75246

Lead Principal Investigator: Goran Klintmalm, MD

For further information about this study, please contact: 214-820-6622 or dianejoh@baylorhealth.edu or you can complete our online form and a research coordinator will get back to you.