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

This study has been terminated.
(Feasibility)
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Ashtar Chami, Emory University
ClinicalTrials.gov Identifier:
NCT01636466
First received: July 5, 2012
Last updated: May 26, 2015
Last verified: May 2015
Results First Received: May 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Failure, Chronic
Intervention: Drug: Everolimus

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Everolimus Conversion Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
Control Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.

Participant Flow:   Overall Study
    Everolimus Conversion     Control  
STARTED     1     0  
COMPLETED     0     0  
NOT COMPLETED     1     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Everolimus Conversion Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
Control Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
Total Total of all reporting groups

Baseline Measures
    Everolimus Conversion     Control     Total  
Number of Participants  
[units: participants]
  1     0     1  
Age  
[units: participants]
     
<=18 years     0         0  
Between 18 and 65 years     1         1  
>=65 years     0         0  
Gender  
[units: participants]
     
Female     0         0  
Male     1         1  



  Outcome Measures

1.  Primary:   Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA)   [ Time Frame: 36 months ]

2.  Secondary:   Incidence of Return to Dialysis Dependence   [ Time Frame: 36 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Ashtar Chami
Organization: Emory University
phone: 404-712-7735
e-mail: ashtar.chami@emory.edu



Responsible Party: Ashtar Chami, Emory University
ClinicalTrials.gov Identifier: NCT01636466     History of Changes
Other Study ID Numbers: IRB00059278
CRAD001AUS191T ( Other Identifier: Other )
Study First Received: July 5, 2012
Results First Received: May 26, 2015
Last Updated: May 26, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board