Phase 4
N=150
Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients
Immunosuppression
Bottom Line
View on ClinicalTrials.gov: NCT00299221 ↗Enrolled (actual)
150
Serious AEs
2.0%
Results posted
May 2015
Primary outcome: Primary: Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation — 0.7; 0.65 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tacrolimus (Drug); combination therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Newark Beth Israel Medical Center
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation |
0.7; 0.65 | — |
| SECONDARY Percent of Patients Alive at One Year Post-transplant |
98; 98 | — |
| SECONDARY Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant |
2; 2 | — |
| SECONDARY Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant |
0; 0 | — |
| SECONDARY Mean ISHLT Biopsy Score Over First Year Post-transplant |
0.67; 0.62 | 0.44 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00299221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.