NCT07835581尚未招募3 期
A Multicenter, Phase 3 Randomized, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Tegoprubart Compared With Tacrolimus in Adult Participants Undergoing De Novo Kidney Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 620
- 主要终点
- Efficacy failure rate at 12 months post-transplant, defined as the first occurrence of biopsy proven acute rejection, graft loss, or death
研究概览
简要总结
This study will evaluate the efficacy and safety of tegoprubart compared with tacrolimus in adult participants undergoing first kidney transplantation.
详细描述
This is a multicenter, randomized, active-controlled, open-label study to assess the efficacy and safety of tegoprubart compared with tacrolimus as part of an immunosuppressive regimen in adult participants undergoing first kidney transplantation. Dose regimens will include either tegoprubart (AT-1501) or tacrolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing kidney transplant with a living or deceased donor kidney
- •Adult participants that have reached the age of consent and are ≥18 years of age
- •Written informed consent prior to any study assessment
排除标准
- •Conditions or circumstances that, in the investigator's judgment or according to protocol-defined criteria, would make participation unsafe, interfere with study assessments, or compromise protocol compliance.
研究组 & 干预措施
Comparator Arm
Active Comparator
Tacrolimus
干预措施: Tacrolimus (Drug)
Investigative Arm
Experimental
Tegoprubart
干预措施: Tegoprubart (Drug)
结局指标
主要结局
Efficacy failure rate at 12 months post-transplant, defined as the first occurrence of biopsy proven acute rejection, graft loss, or death
时间窗: 12 months post-transplant
次要结局
- Proportion of participants with for-cause biopsy proven acute rejection, graft loss, or death(12 months post-transplant)
- Participant and graft survival(12 months post-transplant)
- Composite risk-prediction score for kidney allograft survival(12 months post-transplant)
- Mean Renal graft function as assessed by estimated glomerular filtration rate(12 months post-transplant)
- Incidence of new-onset diabetes after transplantation(12 months post-transplant)
- Incidence of new or worsening hypertension(12 months post-transplant)
- Incidence of new or worsening hyperlipidemia(12 months post-transplant)
- Proportion of participants experiencing deterioration on Patient Reported Outcomes(12 months post-transplant)
- Incidence of delayed graft function(Initial post-transplant period)
研究者
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