Overview
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.
Description
The purpose of this study is to evaluate the safety and efficacy of TCD601 (siplizumab), an anti-CD2 monoclonal antibody, in combination with a CNI-free regimen of belatacept, MPA, and corticosteroids compared to a standard of care CNI-based regimen of tacrolimus, ATG, MPA and corticosteroids in de novo renal transplant patients.
Eligibility
Key Inclusion Criteria:
- Able to understand the study requirements and provide written informed consent before and study assessment is performed
- Male or female patients ≥ 18 to 70 years of age
- Recipients of a de novo renal allograft from a heart-beating deceased, living ABO compatable, non-HLA identical living related donor
Key Exclusion Criteria:
- Subjects who have received a kidney allograft previously
- Recipient of a kidney from an HLA identical living related donor
- Recipient of a kidney from a donor after cardiac death