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

Assessment of Gastrointestinal Tolerability and Efficacy of Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients

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.

Study Overview

• Status: Completed
• Conditions: Heart Transplantation; Gastrointestinal Symptoms
• Intervention / Treatment: Drug: Mycophenolate Sodium

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Enteric-coated Mycophenolate Sodium (Myfortic); 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months	Drug: Mycophenolate Sodium; 1440mg/day (720mg by mouth, twice a day); Other Names: Myfortic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GI Tolerability as Measured by GSRS	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.	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection.	Number of biopsy proven acute rejection, graft loss, and death due to rejection. Number of rejection episodes where rejection is defined as Grade 1B or higher on myocardial biopsy as measured by the 1990 Grading System of the International Society of Heart and Lung Transplantation for Acute Cellular Rejection. Grading system has: grade 0 (no acute rejection); grade 1A (Focal, mild acute rejection); grade 1B (Diffuse, mild acute rejection); grade 2 (Focal, moderate acute rejection); grade 3A (multifocal moderate rejection); grade 3B (Diffuse, borderline severe acute rejection); grade 4 (Severe acute rejection).	6 months

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: Novartis Pharmaceuticals
• Investigators: Principal Investigator: Ernst Schwarz, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: December 13, 2007
• First Submitted That Met QC Criteria: December 14, 2007
• First Posted (ESTIMATE): December 17, 2007

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Heart Transplant; GI; gastrointestinal; Myfortic; Cellcept; GI symptoms with Mycophenolate Mofetil post heart transplant
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid
• Other Study ID Numbers: 9810