- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01636466
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)
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
---|---|
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
|
36 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ashtar Chami, MD, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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.
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