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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ITB-Med LLC
- 入组人数
- 76
- 试验地点
- 29
- 主要终点
- The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TCD601 (siplizumab)
TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids
干预措施: Corticosteroids (Drug)
TCD601 (siplizumab)
TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids
干预措施: belatacept (Biological)
TCD601 (siplizumab)
TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids
干预措施: TCD601 (Biological)
ATG
Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids
干预措施: Corticosteroids (Drug)
ATG
Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids
干预措施: TAC (Drug)
ATG
Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids
干预措施: MPA (Drug)
TCD601 (siplizumab)
TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids
干预措施: MPA (Drug)
ATG
Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids
干预措施: ATG (Drug)
结局指标
主要结局
The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2
时间窗: 12 months
The number of adverse events and serious adverse events
次要结局
- Renal function in Arm 1 compared to Arm 2(12 months)