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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Emory University
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Ashtar Chami, Emory University
ClinicalTrials.gov Identifier:
NCT01636466
First received: July 5, 2012
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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 Transplantation
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:
  • Prevention of allosensitization [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Development of new donor-specific alloantibody using solid bead phase array (Luminex) technology


Secondary Outcome Measures:
  • Incidence of return to dialysis dependence [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus conversion
Everolimus (Zortress) dosed at 0.75 mg bid, with weaning of calcineurin inhibitor
Drug: Everolimus
Everolimus initially dosed at 0.75 mg p.o. bid and dose adjusted to maintain serum trough concentrations of 5-8 ng/ml
Other Name: Zortress
No Intervention: Calcineurin Inhibitor
continuation of current immunosuppressive regimen, with weaning once return to chronic dialysis therapy is required

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01636466

Contacts
Contact: Ashtar Chami, MD 404-712-7735 Ashtar.chami@emory.edu
Contact: Jennifer Brosseau, RN 404-712-1161 jbross2@emory.edu

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

No publications provided

Responsible Party: Ashtar Chami, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01636466     History of Changes
Other Study ID Numbers: IRB00059278, CRAD001AUS191T
Study First Received: July 5, 2012
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Emory University:
Chronic allograft failure

Additional relevant MeSH terms:
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014