A 12-Month, Randomized, Open-Label, Phase IIA Study Evaluating the Safety and Efficacy of Siplizumab in Combination with Belatacept and MPA Compared to Standard of Care Immunosuppression in de novo Renal Transplant Recipients (ASCEND)
Brief description of study
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, mycophenolic acid (MPA) and corticosteroids compared to a standard of care CNI-based regimen of tacrolimus, ATG, MPA and corticosteroids in de novo renal transplant patients.
The rationale for combining siplizumab with belatacept is based on their unique mechanisms of action, which may allow for CNI-avoidance, preserving renal function, and facilitating prophylaxis of acute rejection.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Renal Transplantation
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Age: Between 18 Years - 70 Years
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Gender: All
Key Inclusion Criteria:
- Male or female subjects ≥18 to 70 years of age.
- Recipient of an ABO-compatible, non-human leukocyte antigen (HLA) identical, de novo primary, living or deceased donor kidney transplant.
- Epstein-Barr virus (EBV) seropositive according to local practice.
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
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