Condition: Heart transplant
Key Inclusion Criteria
- Undergoing first allograft transplant
- Men and non-pregnant women who are 18 to 70 years old
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to transplantation.
Key Exclusion Criteria
- Allergy to thymoglobulin
- Previous organ transplants
- Receiving multiple organs
Full Study Name
A Pilot Randomized Study to Assess the Effect and Safety Profile of Thymoglobulin in Primary Cardiac Transplant Recipients: A 12 Month, Single-Center, Randomized, Open-Label Study of Efficacy Comparing Immediate Treatment With and Without Thymoglobulin 1.5 mg/kg/d for 5 Consecutive Days in Heart Transplant Recipients (IRB no. 49697)
The purpose of this study is to determine whether giving an investigational drug called thymoglobulin immediately after heart transplant for 5 days will prevent patients from developing a disease called cardiac allograft vasculopathy (CAV). In CAV, the blood vessels in the transplanted heart develop blockages. Thymoglobulin is a drug that works by suppressing the immune system; previous studies have suggested that thymoglobulin might prevent the development of CAV.
Patients in this study will continue to receive their usual anti-rejection medication regimen. Researchers will also examine participants’ blood samples to determine how their immune system reacts to treatment with thymoglobulin. Thymoglobulin is approved by the U.S. Food and Drug Administration (FDA) for renal transplant recipients, but it is not approved by the FDA for cardiac transplant recipients.