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

This study is currently recruiting participants.
Verified by Cedars-Sinai Medical Center, March 2008

Sponsors and Collaborators: Cedars-Sinai Medical Center
Novartis
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00574197
  Purpose

Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of myocphenolate 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 Transplant
Drug: Mycophenolate Sodium
Phase IV

MedlinePlus related topics:   Heart Transplantation   

ChemIDplus related topics:   Mycophenolate Mofetil    Mycophenolate mofetil hydrochloride    Mycophenolate sodium    Mycophenolic acid   

U.S. FDA Resources

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

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:   January 2009

Arms Assigned Interventions
1
all subjects switched from Myocphenolate 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:

  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.
  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

Investigators
Principal Investigator:     Ernst Schwarz, MD     Cedars-Sinai Medical Center    
  More Information

Responsible Party:   Cedars-Sinai Medical Center ( Ernst Schwarz, MD )
Study ID Numbers:   9810
First Received:   December 13, 2007
Last Updated:   March 13, 2008
ClinicalTrials.gov Identifier:   NCT00574197
Health Authority:   United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Heart Transplant  
gastrointestinal  
Cellcept  
Myfortic
GI
GI symptoms with Myocphenolate Mofetil after heart transplant

Study placed in the following topic categories:
Mycophenolate mofetil
Mycophenolic Acid

Additional relevant MeSH terms:
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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