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

July 5, 2012
June 23, 2014
June 2013
January 2016   (final data collection date for primary outcome measure)
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
Prevention of allosensitization [ Designated as safety issue: No ]
Development of new donor-specific alloantibody using solid bead phase array (Luminex) technology
Complete list of historical versions of study NCT01636466 on ClinicalTrials.gov Archive Site
Incidence of return to dialysis dependence [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Incidence of return to dialysis dependence [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
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
  • Experimental: Everolimus conversion
    Everolimus (Zortress) dosed at 0.75 mg bid, with weaning of calcineurin inhibitor
    Intervention: Drug: Everolimus
  • No Intervention: Calcineurin Inhibitor
    continuation of current immunosuppressive regimen, with weaning once return to chronic dialysis therapy is required
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
January 2017
January 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Ashtar Chami, MD 404-712-7735 Ashtar.chami@emory.edu
Contact: Jennifer Brosseau, RN 404-712-1161 jbross2@emory.edu
United States
 
NCT01636466
IRB00059278, CRAD001AUS191T
Yes
Ashtar Chami, Emory University
Ashtar Chami
Novartis Pharmaceuticals
Principal Investigator: Ashtar Chami, MD Emory University
Emory University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP