Assessment of Gastrointestinal Tolerability and Efficacy of Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- GI Tolerability as Measured by GSRS
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Enteric-coated Mycophenolate Sodium (Myfortic)
1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
Intervention: Mycophenolate Sodium (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection.(6 months)
Investigators
Lawrence Czer
MD
Cedars-Sinai Medical Center