Phase 4
Completed N=11
Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
Source: ClinicalTrials.gov NCT00574197 ↗Enrolled (actual)
11
Serious AEs
72.7%
Results posted
Jul 2020
Primary outcomePrimary: GI Tolerability as Measured by GSRS — 55.67; 34.17 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY GI Tolerability as Measured by GSRS |
55.67; 34.17 | — |
| SECONDARY Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection. |
20; 0; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00574197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.