The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/18/2018 |
| Start Date: | September 13, 2018 |
| End Date: | March 31, 2021 |
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.
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.
Inclusion Criteria:
1. Subjects must be undergoing their first allograft transplant
2. Men and non-pregnant women must be 18 to 70 years old
3. Women of childbearing potential must have a negative serum pregnancy test within 7
days prior to transplantation. The sensitivity must be equal to at least 50 mIU/mL.
(Urine test is allowed in addition to serum test in patients where serum results are
delayed)
4. Men with a female partner of child bearing age and women of childbearing potential
must use two reliable forms of contraception simultaneously. Effective contraception
must be used before beginning study drug therapy, and for 4 months following
discontinuation of study drug therapy.
5. Subjects must be willing and capable of understanding the purpose and risks of the
study, and must sign a statement of informed consent
Exclusion Criteria:
1. Allergy to Thymoglobulin-Thymglobulin is contraindicated in patients with history of
allergy or anaphylaxis to rabbit proteins or to any product excipients, or who have
active acute or chronic infections which contraindicate any additional
immunosuppression
2. Previous organ transplants
3. Patients receiving multiple organs
4. Patients > 250 lbs or 114 kgs
5. Patients with chronic renal failure (creatinine > 2.0mg/dl)
6. Patients with PRA ≥ 25%
7. Patients requiring VAD upon completion of transplantation surgery.
8. Women lactating, pregnant, or of childbearing potential, not using, or who are
unwilling to use two reliable forms of contraception simultaneously during the study.
9. Men who are not using a reliable contraceptive method
10. History of a psychological illness or condition which would interfere with the
patient's ability to understand the requirements of the study
11. White blood cell count ≤ 300/mm3, or platelets ≤ 75,000/mm3, or hemoglobin ≤ 6g/dL
12. HIV-1, HTLV-1, chronic Hepatitis B, or chronic Hepatitis C infection
13. Documented or strong suspicion for pre-operative active infection that has not yet
been adequately treated with the recommended course of antimicrobial therapy
14. Presence of any chronic myelosuppressive disease or agent that has resulted in either
chronic leucopenia or chronic thrombocytopenia
15. Active peptic ulcer disease
16. Patients who have received within the past 30 days or require concomitant treatment
with other investigational drugs (except for those listed in section 8.6 "Concomitant
treatment")
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