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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Gastrointestinal Tolerability and Efficacy of Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients

Conditions
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Gastrointestinal Symptoms, Heart Transplantation

Intervention / Treatment
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* Drug: Mycophenolate Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of either sex aged 18 and above who have undergone successful orthotopic heart transplant surgery. Patients who are currently taking Cellcept® and experiencing gastrointestinal side-effects from this standard therapy. Individuals on Cellcept® with total dosage of 2 mg a day or less would be eligible to participate. Patients who are able to give written informed consent. Exclusion Criteria: 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. Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding. Known sensitivity to the study drug or class of the study drug. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study. Use of any other investigational agent in the last 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Enteric-coated Mycophenolate Sodium (Myfortic)<br>1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months | Drug: Mycophenolate Sodium<br>* 1440mg/day (720mg by mouth, twice a day)<br>* Other names: Myfortic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI Tolerability as Measured by GSRS | 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. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection. | 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). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Transplant, gastrointestinal, Cellcept, Myfortic, GI, GI symptoms with Mycophenolate Mofetil post heart transplant