The Everolimus-Transplant Exit Strategy Trial (E-TEST)
This study is not yet open for participant recruitment.
Verified November 2012 by Emory University
Sponsor:
Allan D Kirk, MD, PhD
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Allan D Kirk, MD, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT01636466
First received: July 5, 2012
Last updated: November 5, 2012
Last verified: November 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Kidney Transplantation |
Drug: Everolimus |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Zortress (Everolimus) to Prevent Alloantibody Formation in Patients With Late Stage Renal Allograft Failure: The Everolimus-Transplant Exit Strategy Trial (E-TEST) |
Resource links provided by NLM:
Further study details as provided by Emory University:
Primary Outcome Measures:
- Prevention of allosensitization [ Time Frame: 36 months ] [ Designated as safety issue: No ]Development of new donor-specific alloantibody using solid bead phase array (Luminex) technology
Secondary Outcome Measures:
- Incidence of return to dialysis dependence [ Time Frame: 36 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Everolimus conversion
Everolimus (Zortress) dosed at 0.75 mg bid, with weaning of calcineurin inhibitor
|
Drug: Everolimus
Everolimus initially dosed at 0.75 mg p.o. bid and dose adjusted to maintain serum trough concentrations of 5-8 ng/ml
Other Name: Zortress
|
|
No Intervention: Calcineurin Inhibitor
continuation of current immunosuppressive regimen, with weaning once return to chronic dialysis therapy is required
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 but greater than or equal to 20 ml/min
- Grade 2 or 3 Interstitial fibrosis/tubular atrophy (IF/TA) on renal allograft biopsy within 3 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 6 months 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636466
Contacts
| Contact: Ashtar Chami, MD | 404-712-7735 | Ashtar.chami@emory.edu |
| Contact: Beth Begley, RN | 404-712-7168 | beth.begley@emoryhealthcare.org |
Locations
| United States, Georgia | |
| Emory University | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: Ashtar Chami, MD | |
Sponsors and Collaborators
Allan D Kirk, MD, PhD
Novartis Pharmaceuticals
Investigators
| Principal Investigator: | Ashtar Chami, MD | Emory University |
More Information
No publications provided
| Responsible Party: | Allan D Kirk, MD, PhD, Scientific Director, Emory Transplant Center, Emory University |
| ClinicalTrials.gov Identifier: | NCT01636466 History of Changes |
| Other Study ID Numbers: | CRAD001AUS191T |
| Study First Received: | July 5, 2012 |
| Last Updated: | November 5, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Emory University:
|
Chronic allograft failure |
Additional relevant MeSH terms:
|
Everolimus Sirolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013