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

Sponsor:	Cedars-Sinai Medical Center
Collaborator:	Novartis Pharmaceuticals
Information provided by:	Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT00574197

Purpose

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.

Condition	Intervention	Phase
Gastrointestinal Symptoms Heart Transplantation	Drug: Mycophenolate Sodium	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Assessment of Gastrointestinal Tolerability and Efficacy of Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients

Resource links provided by NLM:

MedlinePlus related topics: Heart Transplantation

Drug Information available for: Mycophenolic acid Mycophenolate sodium Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:

Side-effects using the GSRS (Gastrointestinal Symptoms Rating Scale), GI complications and GI adverse events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of biopsy proven acute rejection, graft loss, and death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 all subjects switched from Mycophenolate Mofetil to Mycophenolate Sodium	Drug: Mycophenolate Sodium 1440mg/day (720mg by mouth, twice a day)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574197

Contacts

Contact: David Gallegos, RN

(310) 423-4993

gallegosd@cshs.org

Locations

United States, California
Cedars- Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Novartis Pharmaceuticals

Investigators

Principal Investigator:

Ernst Schwarz, MD

Cedars-Sinai Medical Center

More Information

No publications provided

Responsible Party:	Cedars-Sinai Medical Center ( Ernst Schwarz, MD )
Study ID Numbers:	9810
Study First Received:	December 13, 2007
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00574197 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:

Heart Transplant
gastrointestinal
Cellcept

Myfortic
GI
GI symptoms with Mycophenolate Mofetil after heart transplant

Additional relevant MeSH terms:

Immunologic Factors
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Mycophenolic Acid
Enzyme Inhibitors

Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Signs and Symptoms
Digestive System Diseases
Therapeutic Uses
Mycophenolate mofetil

ClinicalTrials.gov processed this record on November 30, 2009