The Everolimus-Transplant Exit Strategy Trial (E-TEST)

Zortress (Everolimus) to Prevent Alloantibody Formation in Patients With Late Stage Renal Allograft Failure: The Everolimus-Transplant Exit Strategy Trial (E-TEST)

The purpose of this study is to test the safety and effectiveness of everolimus (Zortress®) in preventing antibody formation in patients with chronic failing kidney transplants. Everolimus (Zortress®) is approved by the U.S. Food and Drug Administration for the prevention of rejection in kidney transplant.

The primary objective for the study is to determine whether conversion of patients with chronic renal graft failure approaching dialysis to an everolimus-based regimen will prevent allosensitization. The secondary objective will be to determine whether conversion of patients with chronic renal graft failure to everolimus (elimination of calcineurin inhibitor) will delay the onset of dialysis.

Inclusion Criteria:

• recipient of deceased or living donor kidney transplant
• Age 18-75 years (inclusive)
• Male or female
• renal allograft dysfunction/deterioration evidenced by glomerular filtration rate (GFR) less than or equal to 35
• Grade 2 or 3 Interstitial fibrosis/tubular atrophy (IF/TA) on renal allograft biopsy within 5 years of enrollment
• Willing and able to provide informed consent for study participation

Exclusion Criteria:

• Prior solid organ transplant (other than kidney)
• History of donor-specific antibody
• History of biopsy-proven acute rejection within 1 year prior to enrollment
• Proteinuria greater than or equal to 1.5 gm on spot urine protein/creatinine ratio
• Evidence of Hepatitis C virus infection (antibody positive or polymerase chain reaction(PCR) positive)
• Epstein Barr Virus (EBV) or cytomegalovirus (CMV) viremia at the time of enrollment
• Subjects receiving belatacept (Nulojix)
• Pregnant or nursing (lactating) women
• Women of child-bearing potential (WOCBP) who are unwilling or unable to use two birth-control methods throughout participation in the study