Clinical trial NCT00574197: Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
Official title: Assessment of Gastrointestinal Tolerability and Efficacy of Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Symptoms
Heart Transplantation
Keywords: Heart Transplant
gastrointestinal
Cellcept
Myfortic
GI
GI symptoms with Mycophenolate Mofetil post heart transplant
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2007-12-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: GI Tolerability as Measured by GSRS
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection.
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars- Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Ernst Schwarz, MD
role: PRINCIPAL_INVESTIGATOR
References: