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

StatusEnrolling by Invitation
PhasePhase 2
Started2018-09-13
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 14, 2026 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-01-12
Study Status v11
Primary completion date2025-10-31→2026-03-31
Completion date2025-10-31→2026-03-31
2024-12-12
Study Status v10
Primary completion date2024-10-31→2025-10-31
2023-11-22
Study Status, Document Section v9
Re-verified, no change to tracked fields
2022-11-11
Study Status, Eligibility, Document Section v8
Completion date2024-10-31→2025-10-31
Eligibility criteria-92 characters
Inclusion Criteria for Study Entry: Subjects must be undergoing their first allograft transpla [...] atinine < 2.0 mg/dl at time of transplant Exclusion Criteria for Study Entry: Allergy to Thymoglobulin-ThymglobulinThymoglobulin is contraindicated in patients with history of allergy or a [...] gan transplants Patients receiving multiple organs Patients >with 250a lbsBMI orhigher 114than kgs35 Patients with PRA ≥ 25% Patients requiring VAD upon completion of transplantation surgery. History of a psychological illness or condition which would interfere with the patient's ability to understand the requirement [...] [...]
2021-10-20
Study Status v7
Primary completion date2021-06-22→2024-10-31
Completion date2021-06-30→2024-10-31
Show 6 earlier versions
2020-10-14
Study Status, Contacts/Locations v6
Primary completion date2020-10-01→2021-06-22
Study sites1→2
2020-08-05
Active, Not Recruiting→Enrolling by Invitation Study Status v5
Trial statusActive, Not Recruiting→Enrolling by Invitation
2020-04-08
Enrolling by Invitation→Active, Not Recruiting Study Status v4
Trial statusEnrolling by Invitation→Active, Not Recruiting
2019-09-30
Study Status, Eligibility v3
Completion date2021-03-31→2021-06-30
Eligibility criteria-218 characters
[...] of the study, and must sign a statement of informed consent Subjects with a Creatinine < 2.0 mg/dl at time of transplant Exclusion Criteria: Allergy to Thymoglobulin-Thymglobulin is [...] nts receiving multiple organs Patients > 250 lbs or 114 kgs Patients with chronic renal failure (creatinine > 2.0mg/dl) Patients with PRA ≥ 25% Patients requiring VAD upon completion of transplantation surgery. Women lactating, pregnant, or of childbearing potential, not using, or who are unwilling to use two reliable forms of contraception simultaneously during the study. Men who are not using a reliable contracept [...] [...]
2018-10-10
Not Yet Recruiting→Enrolling by Invitation Study Status, Oversight, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Enrolling by Invitation
PhaseNot applicable→Phase 2
Primary completion date2019-10-01→2020-10-01
Completion date2019-10-01→2021-03-31
Start dateestimated 2018-09-01→confirmed 2018-09-13
Study sites0→1
Secondary endpoints22 to 29 entries
Death/Re-transplant Hemodynamic compromise rejection Graft dysfunction Cellular rejection Antibody mediated rejected Cardiac Allograft Vasculopathy (CAV) Any treated rejection
Primary endpoints6 to 1 entries
AntibodyPercentage mediatedof rejected CardiacParticipants AllograftWith VasculopathyComposite (CAV) CellularEfficacy rejection Death/Re-transplant GraftFailure dysfunction Hemodynamicat compromise12 rejectionMonths
2018-07-16
Study Status v1
Start date2017-10-01→2018-09-01
2017-09-22
Original filing
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.
Trial Details
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