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

NCT00574197 | Completed Phase 4 Results

• 1 other identifier: 9810
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Symptoms; Heart Transplantation

Keywords

Heart Transplant; gastrointestinal; Cellcept; Myfortic; GI; GI symptoms with Mycophenolate Mofetil post heart transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection.

  6 months

Study Arms (1)

Enteric-coated Mycophenolate Sodium (Myfortic)

OTHER

1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months

Drug: Mycophenolate Sodium

Interventions

Mycophenolate Sodium DRUG

1440mg/day (720mg by mouth, twice a day)

Also known as: Myfortic

Enteric-coated Mycophenolate Sodium (Myfortic)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Cedars- Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Limitations and Caveats

This is a small sample size study and 3 participants did not finish the 6 month visit

Results Point of Contact

• Title: Ernst Schwarz, MD, PhD
• Organization: Cedars-Sinai Medical Center

Ernst.Schwarz@cshs.org

(310) 840-7089

Study Officials

• Ernst Schwarz, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 17, 2007
• Study Start: June 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 30, 2020
• Results First Posted: July 8, 2020

Record last verified: 2020-07

Locations

US (1)