drugset / Trial / NCT03644667
Tocilizumab in Cardiac Transplantation
Phase 2
Completed
385 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
PPD Development, LP · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Specifically, the investigators will evaluate whether taking tocilizumab leads to less rejection, less development of unwanted antibodies, and better heart function.
Timeline
- Start
- 2018-12-20
- Primary completion
- 2025-03-25
- Completion
- 2025-03-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/kg | Intravenous |
| Background | Methylprednisolone | Other / unclassified | — | — |
| Background | Mycophenolate Mofetil | Small molecule | — | — |
| Background | Mycophenolate Sodium | Unknown | — | — |
| Background | Prednisone | Other / unclassified | — | — |
| Background | Tacrolimus | Small molecule | — | Other |
Indications
No indication recorded.