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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
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Start Date
September 13, 2018
Primary Completion Date
March 31, 2026
Completion Date
March 31, 2026
Last Updated
January 14, 2026
60
ESTIMATED participants
Thymoglobulin
DRUG
Mycophenolate Mofetil
DRUG
Tacrolimus
DRUG
Sirolimus
DRUG
Corticosteroids
DRUG
Lead Sponsor
Cedars-Sinai Medical Center
Collaborators
NCT07359690
NCT07291258
Data Source & Attribution
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