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

Phase 3TerminatedNCT01636466

Ashtar Chami1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Failure, Chronic

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA)

Development of new donor-specific alloantibody as determined by solid phase bead array (Luminex) technology defining MFIs for fine specificity at Class I and Class II antigens (human leukocyte antigens (HLA) - A, B, C, DR, DP, and DQ) with an MFI \>5000 defined as positive

Time frame: 36 months

Secondary Outcomes

Incidence of Return to Dialysis Dependence