Tacrolimus/Everolimus Versus Tacrolimus/Enteric-Coated Mycophenolate Sodium

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gaetano Ciancio, University of Miami
ClinicalTrials.gov Identifier:
NCT01680861
First received: March 6, 2012
Last updated: October 21, 2016
Last verified: October 2016
Results First Received: June 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Transplant; Failure, Kidney
Interventions: Drug: Tacrolimus
Drug: Everolimus
Drug: Enteric Coated Mycophenolate Sodium (EC-MPS)
Drug: Corticosteroids

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tacrolimus/Everolimus our experimental maintenance arm: Target 12-hr Tacrolimus trough level: 5-8 ng/mL Target 12-hr Everolimus trough level: 3-8 ng/mL.
Tacrolimus/EC-MPS our standard maintenance arm: Target 12-hr Tacrolimus trough level: 5-8 ng/mL Target EC-MPS dose: 720 mg PO BID (as tolerated).

Participant Flow for 2 periods

Period 1:   Early Post-transplant Period
    Tacrolimus/Everolimus   Tacrolimus/EC-MPS
STARTED   16 [1]   16 [2] 
COMPLETED   15   15 
NOT COMPLETED   1   1 
Protocol Violation                1                1 
[1] One patient didn't produce sufficient urine during first 24hr post-transplant (ineligible).
[2] One patient developed immediate DGF (delayed graft function) and was therefore ineligible.

Period 2:   First 12 Months Post-transplant
    Tacrolimus/Everolimus   Tacrolimus/EC-MPS
STARTED   15   15 
COMPLETED   15   15 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Tacrolimus/Everolimus our experimental maintenance arm.
Tacrolimus/EC-MPS our standard maintenance arm.
Total Total of all reporting groups

Baseline Measures
   Tacrolimus/Everolimus   Tacrolimus/EC-MPS   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.9  (10.5)   48.5  (11.2)   49.2  (10.8) 
Gender 
[Units: Participants]
     
Female   3   4   7 
Male   12   11   23 
Race/Ethnicity, Customized 
[Units: Participants]
     
African-American   5   2   7 
Hispanic   7   10   17 
White/Asian   3   3   6 
Region of Enrollment 
[Units: Participants]
     
United States   15   15   30 


  Outcome Measures
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1.  Primary:   BPAR (Biopsy-proven Acute Rejection) Incidence During the First 12 Months Post-transplant   [ Time Frame: 1 year ]

2.  Secondary:   Incidence of Chronic Allograft Nephropathy (CAI) at 12 Months Post-transplant   [ Time Frame: 1 year ]

3.  Secondary:   Graft Loss (Return to Permanent Dialysis or Death)   [ Time Frame: during the first 12 months post-transplant ]

4.  Secondary:   eGFR (Calculated Glomerular Filtration Rate), i.e., Renal Function, at 1 Month Post-transplant.   [ Time Frame: at 1 month post-transplant ]

5.  Secondary:   eGFR (Renal Function) at Month 3 Post-transplant   [ Time Frame: at 3 months post-transplant ]

6.  Secondary:   eGFR (Renal Function) at 6 Months Post-transplant   [ Time Frame: at 6 months post-transplant ]

7.  Secondary:   Discontinuance of Any Study Medication (Tacrolimus, Everolimus, or EC-MPS)   [ Time Frame: during the first 12 months post-transplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jeffrey Gaynor, Ph.D. biostatistician
Organization: Miami Transplant Institute
e-mail: jgaynor@med.miami.edu



Responsible Party: Gaetano Ciancio, University of Miami
ClinicalTrials.gov Identifier: NCT01680861     History of Changes
Other Study ID Numbers: 20110126
Study First Received: March 6, 2012
Results First Received: June 20, 2016
Last Updated: October 21, 2016