Status:
ENROLLING_BY_INVITATION
The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Heart Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Study Entry:
- 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
- Exclusion Criteria for Study Entry:
- Allergy to Thymoglobulin-Thymoglobulin 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 with a BMI higher than 35
- Patients with PRA ≥ 25%
- Patients requiring VAD upon completion of transplantation surgery.
- HIV-1, HTLV-1, chronic Hepatitis B, or chronic Hepatitis C infection
- Documented or strong suspicion for pre-operative active infection that has not yet been adequately treated with the recommended course of antimicrobial therapy
- Presence of any chronic myelosuppressive disease or agent that has resulted in either chronic leucopenia or chronic thrombocytopenia
- Active peptic ulcer disease and active GI bleeding
- 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")
- Patients with a history of AL amyloidosis (TTR amyloids) are permitted
Exclusion
Key Trial Info
Start Date :
September 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03292861
Start Date
September 13 2018
End Date
October 31 2025
Last Update
December 16 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048