Renal Transplantation
Conditions
Brief summary
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.
Detailed 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.
Interventions
Sponsors
ITB-Med LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2 | 12 months | The number of adverse events and serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal function in Arm 1 compared to Arm 2 | 12 months | renal function using estimated glomerular filtration rate (eGFR) |
Countries
United States
Outcome results
None listed