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The Everolimus-Transplant Exit Strategy Trial (E-TEST) (E-TEST)

This study has been terminated.
(Feasibility)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636466
First Posted: July 10, 2012
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Ashtar Chami, Emory University
  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 Failure, Chronic Drug: Everolimus Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Ashtar Chami, Emory University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Incidence of Return to Dialysis Dependence [ Time Frame: 36 months ]

Enrollment: 1
Study Start Date: June 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Everolimus
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Ashtar Chami
Novartis Pharmaceuticals
Investigators
Principal Investigator: Ashtar Chami, MD Emory University
  More Information

Responsible Party: Ashtar Chami, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01636466     History of Changes
Other Study ID Numbers: IRB00059278
CRAD001AUS191T ( Other Identifier: Other )
First Submitted: July 5, 2012
First Posted: July 10, 2012
Results First Submitted: May 26, 2015
Results First Posted: June 8, 2015
Last Update Posted: June 8, 2015
Last Verified: May 2015

Keywords provided by Ashtar Chami, Emory University:
Chronic allograft failure
Kidney Transplantation

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents