Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This was a study to compare less intense immunosuppression with a more traditional approach. The hypothesis was that less immunosuppression will provide similar protection against rejection than typical 2-3 drug therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Newark Beth Israel Medical Center
• Collaborator: Astellas Pharma Inc
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

• Adult (at least 18 years old)

• Undergoing a first heart transplant (no heart/kidney transplants), who receive their transplant at one of the study sites

• Specifically INCLUDED are patients on ventricular assist devices, and allosensitized recipients

Exclusion Criteria:

• Age less than 18

• Inability to provide proper informed consent

• Combined organ transplantation

• Re-Transplantation