Status:
COMPLETED
Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients
Lead Sponsor:
Newark Beth Israel Medical Center
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Immunosuppression
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 typic...
Detailed Description
This was a prospective, randomized, controlled (open-label) trial of 2 different strategies of immunosuppression in de novo post-heart transplant patients. The hypothesis was that immunosuppression wi...
Eligibility Criteria
Inclusion
- 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
- Age less than 18
- Inability to provide proper informed consent
- Combined organ transplantation
- Re-Transplantation
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00299221
Start Date
April 1 2004
End Date
December 1 2009
Last Update
May 28 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
2
Mt. Sinai Cardiovascular Institute
New York, New York, United States, 10029