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Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients (DSA Study)

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Paul Bolin, East Carolina University
ClinicalTrials.gov Identifier:
NCT01044303
First received: January 6, 2010
Last updated: October 16, 2014
Last verified: October 2014
Results First Received: August 27, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Transplant; Failure, Kidney
Intervention: Drug: Myfortic Escalation

  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
No text entered.

Reporting Groups
  Description
Mycophenolic Acid Escalation

Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations.

Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily.


Participant Flow:   Overall Study
    Mycophenolic Acid Escalation  
STARTED     32  
COMPLETED     30  
NOT COMPLETED     2  
Lost to Follow-up                 2  



  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.
No text entered.

Reporting Groups
  Description
Mycophenolic Acid Escalation

Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations.

Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily.


Baseline Measures
    Mycophenolic Acid Escalation  
Number of Participants  
[units: participants]
  32  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     28  
>=65 years     4  
Gender  
[units: participants]
 
Female     12  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     32  



  Outcome Measures
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1.  Primary:   Percent Change in Mean Fluorescence Index (MFI) of Donor Specific Antibodies (DSA) With Increasing Doses of Enteric-Coated Mycophenolate Sodium (EC-MPS)   [ Time Frame: 24 months ]

2.  Secondary:   To Assess the Rate of Rejection, Infection and Renal Function as Mycophenolic Acid Dose is Increased.   [ Time Frame: 24 months ]


  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
Lost to follow-up was a limitation in this study.


  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: Dr. Paul Bolin
Organization: East Carolina University
phone: 252-744-3773
e-mail: bolinp@ecu.edu


No publications provided


Responsible Party: Paul Bolin, East Carolina University
ClinicalTrials.gov Identifier: NCT01044303     History of Changes
Other Study ID Numbers: CERL080A-US78T
Study First Received: January 6, 2010
Results First Received: August 27, 2014
Last Updated: October 16, 2014
Health Authority: United States: Institutional Review Board