|
| Overall Recruitment Status: Active, currently enrolling |
| |
| Official Title |
| 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 |
| |
| Region |
Sponsors |
| California - Southern |
|
| |
| Acronym |
KP IRB No. |
|
12095 |
| |
| Study Type |
Phase |
| Clinical Trial |
Phase II |
| |
| Study Population Description |
| Individuals who are Heart Transplantation Recipients |
| |
| Purpose |
| 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.
|
| |
| Detailed Description |
| Percentage of Participants With Composite Efficacy Failure at 12 Months. Time Frame: 12 Months
Composite efficacy failure is defined as development of de novo donor specific antibodies (measured by standardized alloantibody testing by Luminex and control sera, characterizing kinetics, specificities and relative binding strength) and ischemia on endomyocardial biopsy (characterized on biopsy by myocyte necrosis and/or regions of myocyte dropout) at 12 months post-transplant. |
| |
| Gender |
Age Limit |
| Male & Female |
18 - 70 years |
| |
- Subjects must be undergoing their first allograft transplant
|
-
Men and non-pregnant women must be 18 to 70 years old
|
-
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)
|
-
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
|
-
Subjects must be willing and capable of understanding the purpose and risks of the study, and must sign a statement of informed consent
|
-
Subjects with a Creatinine <2.0 mg/dl at time of transplant
|
- 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
|
-
Previous organ transplants
|
-
Patients receiving multiple organs
|
-
Patients >250 lbs or 114 kgs
|
|
|
-
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 requirements of the study
|
-
Please contact study team for more eligibility criteria
|
|
| |
|
|
|
-
Antibiotics, Antineoplastic
|
|
-
Antibiotics, Antitubercular
|
|
|
|
-
Molecular Mechanisms of Pharmacological Action
|
|
|
|
|
|
-
Physiological Effects of Drugs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|