A Noninterventional Extension Study for Patients Treated in Study R5459-RT-1944 With Vonsetamig (BCMA x CD3 Bispecific Antibody) Who Receive a Kidney Transplant

Regeneron Pharmaceuticals14 个研究点分布在 1 个国家目标入组 20 人2023年10月19日

适应症Chronic Kidney Disease (CKD)

干预措施Noninterventional

概览

阶段: 不适用
干预措施: Noninterventional
疾病 / 适应症: Chronic Kidney Disease (CKD)
发起方: Regeneron Pharmaceuticals
入组人数: 20
试验地点: 14
主要终点: Incidence of Adverse Events
状态: 招募中
最后更新: 15天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2023年10月19日

结束日期

2028年2月23日

最后更新

15天前

研究类型

Observational

性别

All

研究者

发起方

Regeneron Pharmaceuticals

责任方

Sponsor

入排标准

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

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)