NCT05106387招募中不适用
A Noninterventional Extension Study for Patients Treated in Study R5459-RT-1944 With Vonsetamig (BCMA x CD3 Bispecific Antibody) Who Receive a Kidney Transplant
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 14
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
The main purpose of this study is to continue to see how vonsetamig works in the body and to monitor the outcomes after kidney transplant for participants previously treated in the R5459-RT-1944 study (NCT05092347).
No study drug will be given during this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Received at least 1 dose of treatment with vonsetamig in study R5459-RT-1944 [NCT05092347].
- •Received after acceptable crossmatching, a kidney transplant while enrolled in study R5459-RT-1944
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide informed consent signed by study patient or legally acceptable representative
排除标准
- •1.There are no exclusion criteria for this study.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Vonsetamig in study R5459-RT-1944
Received a kidney transplant and were administered vonsetamig in study R5459-RT-1944 [NCT05092347].
干预措施: Noninterventional (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: Up to 12 months post-kidney transplant
Incidence of Serious Adverse Events
时间窗: Up to 12 months post-kidney transplant
次要结局
- Incidence of biopsy-proven kidney allograft rejection(Up to 12 Months)
- Time to diagnosis of biopsy-proven kidney allograft rejection(Up to 12 Months)
- Responsiveness to therapy by 12 months of biopsy-proven kidney allograft rejection(Up to 12 Months)
- Incidence of graft loss(Up to 12 Months)
- Time to graft loss(Up to 12 Months)
- Change in estimated glomerular filtration rate (eGFR) over time(Up to 12 Months)
- Incidence of delayed graft function(Up to Day 7)
- Percent Change in anti-HLA alloantibodies(Up to 12 months)
- Mean Fluorescence Intensity Change in anti-HLA alloantibodies(Up to 12 months)
- Change in Calculated panel-reactive antibody (cPRA) over time(Up to 12 Months)
- Percent Change in donor-specific anti-HLA alloantibodies(Up to 12 Months)
- Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies(Up to 12 Months)
- Incidence of de novo anti-HLA alloantibody development(Up to 12 Months)
- Serum Concentrations of Ig classes (IgG, IgA, and IgM) over time(Up to 12 Months)
- Percent change from baseline of circulating serum concentrations of Ig classes(Up to 12 Months)
- Serum Concentration of vonsetamig(Up to 12 Months)
研究者
研究点 (14)
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