Study Stopped
Feasibility
The Everolimus-Transplant Exit Strategy Trial (E-TEST)
E-TEST
Zortress (Everolimus) to Prevent Alloantibody Formation in Patients With Late Stage Renal Allograft Failure: The Everolimus-Transplant Exit Strategy Trial (E-TEST)
2 other identifiers
interventional
1
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2012
CompletedFirst Posted
Study publicly available on registry
July 10, 2012
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
June 8, 2015
CompletedFebruary 5, 2018
January 1, 2018
11 months
July 5, 2012
May 26, 2015
January 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
36 months
Secondary Outcomes (1)
Incidence of Return to Dialysis Dependence
36 months
Study Arms (2)
Everolimus conversion
EXPERIMENTALSubjects 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.
Control
NO INTERVENTIONSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ashtar Chamilead
- Novartis Pharmaceuticalscollaborator
Study Sites (1)
Emory University
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ashtar Chami
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
Ashtar Chami, MD
Emory University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 5, 2012
First Posted
July 10, 2012
Study Start
June 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
February 5, 2018
Results First Posted
June 8, 2015
Record last verified: 2018-01