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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. Identifier: NCT00574197
Recruitment Status : Completed
First Posted : December 17, 2007
Last Update Posted : July 22, 2010
Novartis Pharmaceuticals
Information provided by:
Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Symptoms Heart Transplantation Drug: Mycophenolate Sodium Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Gastrointestinal Tolerability and Efficacy of Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
Study Start Date : June 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
all subjects switched from Mycophenolate Mofetil to Mycophenolate Sodium
Drug: Mycophenolate Sodium
1440mg/day (720mg by mouth, twice a day)
Other Name: Myfortic

Primary Outcome Measures :
  1. Side-effects using the GSRS (Gastrointestinal Symptoms Rating Scale), GI complications and GI adverse events [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Incidence of biopsy proven acute rejection, graft loss, and death [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00574197

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United States, California
Cedars- Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Novartis Pharmaceuticals
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Principal Investigator: Ernst Schwarz, MD Cedars-Sinai Medical Center

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Responsible Party: Ernst Schwarz, MD, Cedars-Sinai Medical Center Identifier: NCT00574197     History of Changes
Other Study ID Numbers: 9810
First Posted: December 17, 2007    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: August 2009
Keywords provided by Cedars-Sinai Medical Center:
Heart Transplant
GI symptoms with Mycophenolate Mofetil after heart transplant
Additional relevant MeSH terms:
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Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action