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

This study has been terminated.
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Ashtar Chami, Emory University Identifier:
First received: July 5, 2012
Last updated: May 26, 2015
Last verified: May 2015

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.

Condition Intervention Phase
Kidney Failure, Chronic
Drug: Everolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Zortress (Everolimus) to Prevent Alloantibody Formation in Patients With Late Stage Renal Allograft Failure: The Everolimus-Transplant Exit Strategy Trial (E-TEST)

Resource links provided by NLM:

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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

Secondary Outcome Measures:
  • Incidence of Return to Dialysis Dependence [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: June 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus conversion
Subjects who have previously undergone a kidney transplant and are in late stage renal allograft failure will be randomized to take everolimus 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects will be weaned off of all other immunosuppression medicines when dialysis starts.
Drug: Everolimus
Everolimus will initially be dosed at 0.75 mg tablet taken orally twice a day. The dose will be adjusted to maintain serum trough concentrations of 5-8 ng/ml.
Other Name: Zortress
No Intervention: Control
Subjects who have previously undergone a kidney transplant and are in late stage renal allograft failure will be randomized to continue on current immunosuppressive regimen. Subjects will be weaned off of all immunosuppression medicines when dialysis starts.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01636466

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Ashtar Chami
Novartis Pharmaceuticals
Principal Investigator: Ashtar Chami, MD Emory University
  More Information

No publications provided

Responsible Party: Ashtar Chami, Assistant Professor, Emory University Identifier: NCT01636466     History of Changes
Other Study ID Numbers: IRB00059278, CRAD001AUS191T
Study First Received: July 5, 2012
Results First Received: May 26, 2015
Last Updated: May 26, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Emory University:
Chronic allograft failure
Kidney Transplantation

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on October 08, 2015