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

This study has been terminated.
(Feasibility)
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Ashtar Chami, Emory University
ClinicalTrials.gov Identifier:
NCT01636466
First received: July 5, 2012
Last updated: May 26, 2015
Last verified: May 2015

July 5, 2012
May 26, 2015
June 2013
May 2014   (final data collection date for primary outcome measure)
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
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 Failure, Chronic
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
  • 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.
    Intervention: Drug: Everolimus
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
May 2014
May 2014   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01636466
IRB00059278, CRAD001AUS191T
Yes
Not Provided
Not Provided
Ashtar Chami, Emory University
Ashtar Chami
Novartis Pharmaceuticals
Principal Investigator: Ashtar Chami, MD Emory University
Emory University
May 2015

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