The goal of the EVEREST study is to modify anti-rejection medications and then gradually reduce them over a period of time until the medication(s) are stopped. This is called immunosuppression withdrawal.
In this study, tacrolimus and mycophenolate will be first replaced by everolimus. Everolimus is FDA approved as an anti-rejection drug after a liver transplant when used with tacrolimus. However, everolimus is not yet FDA approved to be taken without tacrolimus after a liver transplant.
A second drug, epoetin alfa or EPO (Procrit®) is a man-made version of human erythropoietin. Erythropoietin is produced naturally in the body, mostly in the kidneys. It stimulates the bone marrow to make more red blood cells.
Researchers think that using everolimus and EPO together could increase Treg production. After taking these two medications together for a while, the anti-rejection medication, everolimus, will be gradually reduced and then stopped. This is called ‘immunosuppression withdrawal’.
Participating in EVEREST
The EVEREST study has 3 phases: the Screening phase, the Investigational Therapy and Immunosuppression Withdrawal phase, and the Follow-up phase. Depending on the phase of the study and your outcome, visit schedules will vary. In total, participation may last between 4 and 4.5 years.
|
Phase |
Study Visits |
Duration |
|
Screening phase |
2 |
12-14 weeks |
|
Investigational therapy and immunosuppression withdrawal phase
|
13 |
14 months |
|
Follow-up phase |
8 |
3 years |
To participate in the study, you must come to the study center for certain visits; other visits can be done over the phone. In general, study visits will consist of a brief physical exam, some visits will also include blood and liver biopsy collections and some visits will include study medication administration.
Learn whether you might be eligible for EVEREST.