The Everolimus-Transplant Exit Strategy Trial (E-TEST) (E-TEST)
January 9, 2018 updated by: Ashtar Chami
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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 Names:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA)
Time Frame: 36 months
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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
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of Return to Dialysis Dependence
Time Frame: 36 months
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36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ashtar Chami, MD, Emory University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
July 5, 2012
First Submitted That Met QC Criteria
July 5, 2012
First Posted (Estimate)
July 10, 2012
Study Record Updates
Last Update Posted (Actual)
February 5, 2018
Last Update Submitted That Met QC Criteria
January 9, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00059278
- CRAD001AUS191T (Other Identifier: Other)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.