The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients
Status:
Enrolling by invitation
Trial end date:
2024-10-31
Target enrollment:
Participant gender:
Summary
This is a randomized, controlled, single center study to evaluate the efficacy of
Thymoglobulin induction therapy in combination with Mycophenolate Mofetil, tacrolimus, and
steroids in the prevention of CAV. Approximately half of the patients will be randomized to
receive a total of 5 doses of Thymoglobulin during the study. The first dose of Thymoglobulin
will be administered at 1.5 mg/kg via intravenous infusion over 6 hours immediately upon
arrival to the ICU post-operation (day 1). Subsequent doses of 1.5 mg/kg will be administered
on days 2, 3, 4, and 5 via IV infusion over 4 hours.
Mechanistic assays (T-reg cells, Lym subsets, B cell subsets, IL-1b, cytokines, TGFb, IL-21
to be drawn at Pre-transplant, 3, 6, 12 months post-transplant) will also be performed.
All patients will be followed and monitored according to standard of care protocols for heart
transplant recipients at our center.