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Trial record 45 of 1234 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

Tracking Information
First Submitted Date  ICMJE December 13, 2007
First Posted Date  ICMJE December 17, 2007
Results First Submitted Date  ICMJE June 21, 2020
Results First Posted Date  ICMJE July 8, 2020
Last Update Posted Date July 30, 2020
Study Start Date  ICMJE June 2006
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2020)
GI Tolerability as Measured by GSRS [ Time Frame: Baseline and 6 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2007)
Side-effects using the GSRS (Gastrointestinal Symptoms Rating Scale), GI complications and GI adverse events [ Time Frame: 6 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2020)
Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection. [ Time Frame: 6 months ]
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2007)
Incidence of biopsy proven acute rejection, graft loss, and death [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
Official Title  ICMJE Assessment of Gastrointestinal Tolerability and Efficacy of Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
Brief Summary Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of Cellcept®. The new enteric-coated, Myfortic® is presently FDA approved for the prevention of acute kidney rejection only. There is no clinical data of its use in heart transplant patients.
Detailed Description This is an open-labeled, prospective, non-randomized pilot-phase study of the enteric-coated, Myfortic® versus the non enteric-coated, Cellcept® in patients who are within 5 years of having undergone heart transplant surgery who are currently taking Cellcept®. After the initial screening, 20 patients who fulfill the inclusion criteria and report symptoms of gastrointestinal side-effects while taking Cellcept will be switched to Myfortic. All 20 patients will be followed closely over a period of 6 months following enrollment. Concomitant immunosuppressive therapy will continue in all patients per standard treatment protocol.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastrointestinal Symptoms
  • Heart Transplantation
Intervention  ICMJE Drug: Mycophenolate Sodium
1440mg/day (720mg by mouth, twice a day)
Other Name: Myfortic
Study Arms  ICMJE Enteric-coated Mycophenolate Sodium (Myfortic)
1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
Intervention: Drug: Mycophenolate Sodium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2010)
11
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2007)
20
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients of either sex aged 18 and above who have undergone successful orthotopic heart transplant surgery.
  2. Patients who are currently taking Cellcept® and experiencing gastrointestinal side-effects from this standard therapy.
  3. Individuals on Cellcept® with total dosage of 2 mg a day or less would be eligible to participate.
  4. Patients who are able to give written informed consent.

Exclusion Criteria:

  1. Patients with an absolute neutrophil count <1500 cells/mm3, and/or leukocytopenia (<2500 cells/mm3), thrombocytopenia (<75,000 cells/mm3) and significant anemia (hemoglobin < 6g/dl) at the time of potential enrollment.
  2. Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding.
  3. Known sensitivity to the study drug or class of the study drug.
  4. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
  5. Use of any other investigational agent in the last 30 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00574197
Other Study ID Numbers  ICMJE 9810
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lawrence Czer, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE Novartis Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Ernst Schwarz, MD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP