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Trial record 45 of 1233 for:    MYCOPHENOLIC ACID

Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients

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.
 
ClinicalTrials.gov Identifier: NCT00574197
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : July 8, 2020
Last Update Posted : July 30, 2020
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Lawrence Czer, Cedars-Sinai Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gastrointestinal Symptoms
Heart Transplantation
Intervention Drug: Mycophenolate Sodium
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enteric-coated Mycophenolate Sodium (Myfortic)
Hide Arm/Group Description 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
Period Title: Overall Study
Started 11
Completed 6
Not Completed 5
Arm/Group Title Enteric-coated Mycophenolate Sodium (Myfortic)
Hide Arm/Group Description 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  90.9%
>=65 years
1
   9.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
1
   9.1%
Male
10
  90.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title GI Tolerability as Measured by GSRS
Hide Description

Side-effects using the GSRS (Gastrointestinal Symptoms Rating Scale)

GSRS has 15 items, each rated on a 7-point scale from 1 (no discomfort) to 7 (very severe discomfort). GSRS total minimum value is 15; maximum value is 105. Higher scores represent greater discomfort.

Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteric-coated Mycophenolate Sodium (Myfortic)
Hide Arm/Group Description:
1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
GSRS at baseline 55.67  (15.49)
GSRS at 6 months 34.17  (19.47)
2.Secondary Outcome
Title Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection.
Hide Description

Number of biopsy proven acute rejection, graft loss, and death due to rejection.

Number of rejection episodes where rejection is defined as Grade 1B or higher on myocardial biopsy as measured by the 1990 Grading System of the International Society of Heart and Lung Transplantation for Acute Cellular Rejection. Grading system has:

  • grade 0 (no acute rejection)
  • grade 1A (Focal, mild acute rejection)
  • grade 1B (Diffuse, mild acute rejection)
  • grade 2 (Focal, moderate acute rejection)
  • grade 3A (multifocal moderate rejection)
  • grade 3B (Diffuse, borderline severe acute rejection)
  • grade 4 (Severe acute rejection).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enteric-coated Mycophenolate Sodium (Myfortic)
Hide Arm/Group Description:
1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
Overall Number of Participants Analyzed 6
Overall Number of Units Analyzed
Type of Units Analyzed: Myocardial biopsies
20
Count of Units
Unit of Measure: myocardial biopsies
No rejection (Grade 0 or 1A)
20
 100.0%
Rejection (Grade 1B or higher)
0
   0.0%
Death due to rejection
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enteric-coated Mycophenolate Sodium (Myfortic)
Hide Arm/Group Description

Enteric-coated Mycophenolate Sodium (Myfortic)

1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months

All-Cause Mortality
Enteric-coated Mycophenolate Sodium (Myfortic)
Affected / at Risk (%)
Total   1/11 (9.09%)    
Hide Serious Adverse Events
Enteric-coated Mycophenolate Sodium (Myfortic)
Affected / at Risk (%) # Events
Total   8/11 (72.73%)    
Blood and lymphatic system disorders   
Neutropenia *  1/11 (9.09%)  1
Cardiac disorders   
Heart failure *  1/11 (9.09%)  1
Heart re-transplant *  1/11 (9.09%)  1
Hypovolemia *  1/11 (9.09%)  1
Gastrointestinal disorders   
Diarrhea *  4/11 (36.36%)  4
GI Bleeding *  1/11 (9.09%)  1
Immune system disorders   
Anaphylactic reaction *  1/11 (9.09%)  1
Infections and infestations   
Sepsis *  1/11 (9.09%)  1
Metabolism and nutrition disorders   
Failure to thrive *  1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders   
Steroid induced myopathy *  1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia *  1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enteric-coated Mycophenolate Sodium (Myfortic)
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
This is a small sample size study and 3 participants did not finish the 6 month visit
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: Ernst Schwarz, MD, PhD
Organization: Cedars-Sinai Medical Center
Phone: (310) 840-7089
EMail: Ernst.Schwarz@cshs.org
Layout table for additonal information
Responsible Party: Lawrence Czer, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00574197    
Other Study ID Numbers: 9810
First Submitted: December 13, 2007
First Posted: December 17, 2007
Results First Submitted: June 21, 2020
Results First Posted: July 8, 2020
Last Update Posted: July 30, 2020