The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients

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.

NCT Number	NCT03292861
Lead Sponsor	Cedars-Sinai Medical Center Collaborators: Genzyme, a Sanofi Company
Conditions	Heart Transplantation
Enrollment	60 participants
Start Date	2018-09-13
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-14