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

Heart Transplantation Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Gastrointestinal Symptoms
• Heart Transplantation

• NCT number: NCT00574197
• Study type: Interventional
• Source: Cedars-Sinai Medical Center
• Status: Completed
• Phase: Phase 4
• Start date: June 2006
• Completion date: December 2009