Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Adele Rike-Shields, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01336296
First received: October 28, 2010
Last updated: May 20, 2016
Last verified: May 2016
Results First Received: April 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Transplant Recipients
Intervention: Drug: mycophenolic acid

  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
Myfortic Preload

Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)

mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant

Myfortic Standard

Myfortic at time of transplant with Thymoglobulin induction

mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant


Participant Flow:   Overall Study
    Myfortic Preload     Myfortic Standard  
STARTED     40     21  
COMPLETED     35     17  
NOT COMPLETED     5     4  



  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.
Intent to treat

Reporting Groups
  Description
Myfortic Preload

Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)

mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant

Myfortic Standard

Myfortic at time of transplant with Thymoglobulin induction

mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant

Total Total of all reporting groups

Baseline Measures
    Myfortic Preload     Myfortic Standard     Total  
Number of Participants  
[units: participants]
  40     21     61  
Age  
[units: years]
Mean (Standard Deviation)
  55.1  (15)     55.8  (13.1)     55.4  (14)  
Gender  
[units: participants]
     
Female     12     6     18  
Male     28     15     43  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     2     7  
White     35     19     54  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     40     21     61  



  Outcome Measures
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1.  Primary:   Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) at 6 Months   [ Time Frame: Incidence at 3, 6 and 12 months post transplant ]

2.  Secondary:   Severity of Acute Rejection by Banff '97 Criteria   [ Time Frame: Severity 1 year post transplant ]

3.  Secondary:   Difference in Renal Function   [ Time Frame: Difference at 1 month, 3 months, 6 months, 1 year ]

4.  Secondary:   Incidence of Chronic Alloantibody Rejection or Chronic Allograft Arteriopathy by Banff ‘97   [ Time Frame: 1 year ]

5.  Secondary:   Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection   [ Time Frame: 1 year ]


  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: Research Associate Professor
Organization: UCincinnati
phone: 5135852145
e-mail: adele.rike@uc.edu



Responsible Party: Adele Rike-Shields, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01336296     History of Changes
Other Study ID Numbers: Myfortic Preload
Study First Received: October 28, 2010
Results First Received: April 30, 2015
Last Updated: May 20, 2016
Health Authority: United States: Institutional Review Board