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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
Results First Posted : July 8, 2020
Last Update Posted : July 30, 2020
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Lawrence Czer, 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: N/A
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
Enteric-coated Mycophenolate Sodium (Myfortic)
1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
Drug: Mycophenolate Sodium
1440mg/day (720mg by mouth, twice a day)
Other Name: Myfortic

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

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: Lawrence Czer, MD, Cedars-Sinai Medical Center Identifier: NCT00574197    
Other Study ID Numbers: 9810
First Posted: December 17, 2007    Key Record Dates
Results First Posted: July 8, 2020
Last Update Posted: July 30, 2020
Last Verified: July 2020
Keywords provided by Lawrence Czer, Cedars-Sinai Medical Center:
Heart Transplant
GI symptoms with Mycophenolate Mofetil post 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