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Trial record 28 of 1177 for:    MYCOPHENOLIC ACID

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

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ClinicalTrials.gov Identifier: NCT01044303
Recruitment Status : Completed
First Posted : January 7, 2010
Results First Posted : October 20, 2014
Last Update Posted : October 20, 2014
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Paul Bolin, East Carolina University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Transplant; Failure, Kidney
Intervention Drug: Myfortic Escalation
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mycophenolic Acid Escalation
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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.

Period Title: Overall Study
Started 32
Completed 30
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
Arm/Group Title Mycophenolic Acid Escalation
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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.

Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
  87.5%
>=65 years
4
  12.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
12
  37.5%
Male
20
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
1.Primary Outcome
Title Percent Change in Mean Fluorescence Index (MFI) of Donor Specific Antibodies (DSA) With Increasing Doses of Enteric-Coated Mycophenolate Sodium (EC-MPS)
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
This was a pilot study to examine the effect of MPA escalation on DSA reduction.
Arm/Group Title Mycophenolic Acid (MPA) Escalation
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Patients receiving MPA (500mg to 2500mg of CellCept daily or 360mg to 1800mg myfortic daily), cyclosporine or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 6 months
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: percent of MFI change
43.1  (31.45)
2.Secondary Outcome
Title To Assess the Rate of Rejection, Infection and Renal Function as Mycophenolic Acid Dose is Increased.
Hide Description [Not Specified]
Time Frame 24 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rate of Infection Rate of Rejection Renal Function
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Number of patients who had an infection during the course of the study.
Number of patients who had a rejection during the course of the study.
Number of patients who had stable renal function throughout the study.
Overall Number of Participants Analyzed 30 30 30
Measure Type: Number
Unit of Measure: participants
2 2 29
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adverse Events
Hide Arm/Group Description Adverse events reported by participants during the course of the study.
All-Cause Mortality
Adverse Events
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adverse Events
Affected / at Risk (%) # Events
Total   5/30 (16.67%)    
Blood and lymphatic system disorders   
Sepsis  [1]  1/30 (3.33%)  1
Endocrine disorders   
Pancreatitis  [2]  1/30 (3.33%)  1
Gastrointestinal disorders   
Diarrhea  [3]  2/30 (6.67%)  2
Respiratory, thoracic and mediastinal disorders   
Pneumonia  [4]  1/30 (3.33%)  1
Indicates events were collected by systematic assessment
[1]
One subject was hospitalized for Sepsis during the study.
[2]
One subject hospitalized for pancreatitis during the study
[3]
There were two subjects hospitalized for Gastrointestinal complaints and diarrhea.
[4]
One subject was hospitalized for pneumonia during the study period.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Adverse Events
Affected / at Risk (%) # Events
Total   5/30 (16.67%)    
Blood and lymphatic system disorders   
CMV   1/30 (3.33%)  1
Gastrointestinal disorders   
Diarrhea *  3/30 (10.00%)  3
Nausea *  1/30 (3.33%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Lost to follow-up was a limitation in this study.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Paul Bolin
Organization: East Carolina University
Phone: 252-744-3773
EMail: bolinp@ecu.edu
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Responsible Party: Paul Bolin, East Carolina University
ClinicalTrials.gov Identifier: NCT01044303     History of Changes
Other Study ID Numbers: CERL080A-US78T
First Submitted: January 6, 2010
First Posted: January 7, 2010
Results First Submitted: August 27, 2014
Results First Posted: October 20, 2014
Last Update Posted: October 20, 2014