The Everolimus-Transplant Exit Strategy Trial (E-TEST) (E-TEST)
|ClinicalTrials.gov Identifier: NCT01636466|
Recruitment Status : Terminated (Feasibility)
First Posted : July 10, 2012
Results First Posted : June 8, 2015
Last Update Posted : February 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Failure, Chronic||Drug: Everolimus||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Zortress (Everolimus) to Prevent Alloantibody Formation in Patients With Late Stage Renal Allograft Failure: The Everolimus-Transplant Exit Strategy Trial (E-TEST)|
|Study Start Date :||June 2013|
|Primary Completion Date :||May 2014|
|Study Completion Date :||May 2014|
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.
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
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.
- Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA) [ Time Frame: 36 months ]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
- Incidence of Return to Dialysis Dependence [ Time Frame: 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636466
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Ashtar Chami, MD||Emory University|