Kidney Failure, Chronic Clinical Trial
— E-TESTOfficial title:
Zortress (Everolimus) to Prevent Alloantibody Formation in Patients With Late Stage Renal Allograft Failure: The Everolimus-Transplant Exit Strategy Trial (E-TEST)
Verified date | January 2018 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Ashtar Chami | Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Incidence of Return to Dialysis Dependence | 36 months |
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