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

Cedars-Sinai Medical Center

Status and phase: Completed; Phase 4

Conditions: Gastrointestinal Symptoms; Heart Transplantation

Treatments: Drug: Mycophenolate Sodium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00574197

9810

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Enteric-coated Mycophenolate Sodium (Myfortic)

Other group

Description:

1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months

Treatment:

Drug: Mycophenolate Sodium