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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01336296
First Posted: April 15, 2011
Last Update Posted: August 2, 2016
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):
Adele Rike-Shields, University of Cincinnati
Results First Submitted: April 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

1.  Primary:   Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) 3, 6 and 12 Months Post Transplant   [ Time Frame: 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
First Submitted: October 28, 2010
First Posted: April 15, 2011
Results First Submitted: April 30, 2015
Results First Posted: April 11, 2016
Last Update Posted: August 2, 2016