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

This study is currently recruiting participants.
Study NCT00574197.   Last updated on March 13, 2008.   Information provided by Cedars-Sinai Medical Center

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Descriptive Information Fields
Brief Title † Enteric-Coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
Official Title † 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 myocphenolate 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 Phase Phase IV
Study Type † Interventional
Study Design † Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary Outcome Measure † Side-effects using the GSRS (Gastrointestinal Symptoms Rating Scale), GI complications and GI adverse events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure † Incidence of biopsy proven acute rejection, graft loss, and death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Condition † Gastrointestinal Symptoms
Heart Transplant
Intervention † Drug: Mycophenolate Sodium
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 20
Start Date † June 2006
Completion Date January 2009
Eligibility Criteria †

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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: David Gallegos, RN     (310) 423-4993     gallegosd@cshs.org    
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00574197
Organization ID 9810
Secondary IDs ††
Study Sponsor † Cedars-Sinai Medical Center
Collaborators †† Novartis
Investigators †
Principal Investigator:     Ernst Schwarz, MD     Cedars-Sinai Medical Center    
Information Provided By Cedars-Sinai Medical Center
Verification Date March 2008
First Received Date † December 13, 2007
Last Updated Date March 13, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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