Prevention of Cardiac Allograft Vasculopathy Using Rituximab (Rituxan) Therapy in Cardiac Transplantation (CTOT-11)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 362
- 试验地点
- 24
- 主要终点
- Change in Percent Atheroma Volume (PAV)
研究概览
简要总结
All people who have a heart transplant are at risk for developing cardiac allograft vasculopathy (CAV). CAV means narrowing of the heart transplant vessels, which is associated with poor heart transplant function. People who develop antibodies after transplant have a higher risk of developing CAV. Infections, high cholesterol, and rejection also increase the risk of developing CAV. People who develop CAV usually have to receive another transplant.
详细描述
The purpose of this research study is to see if a study drug called rituximab (Rituxan®) prevents CAV. Rituximab destroys certain types of white blood cells called B cells. B cells are important cells in the immune system that help the body fight infection by producing substances called antibodies. B cells and the antibodies they produce are also involved in some kinds of rejection after organ transplantation. Rituximab decreases the number of B cells in the blood and other tissues. The goal of this study is to determine if decreasing B cells with Rituximab can prevent injury to the transplanted heart.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rituximab Placebo
Rituximab Placebo / conventional immunosuppression
干预措施: Rituximab placebo/conventional immunosuppression (tacrolimus, MMF, and steroid taper) (Drug)
Rituximab
Rituximab induction/conventional immunosuppression
干预措施: Rituximab induction/conventional immunosuppression (tacrolimus, MMF, and steroid taper) (Biological)
结局指标
主要结局
Change in Percent Atheroma Volume (PAV)
时间窗: Baseline, 1 year
Nominal or noticeable change, bad or good, from baseline to 1 year in percent atheroma volume (PAV) which is a measure of the degree of coronary arterial obstruction due to host alloimmune processes measured by intravascular ultrasound (IVUS) in a target coronary artery. Thus a decrease in PAV would be an indicator of less obstruction and a better outcome.
次要结局
- Death(12 months)
- Re-transplantation or Re-listed for Transplantation(6 to 12 months)
- Number of Episodes of Biopsy Proven Acute Rejection (BPAR) of Any Grade Per Participant(6 to 12 months)
- Incidence of BPAR (Any Grade)(6 to 12 months)
- Incidence of AMR(6 to 12 months)
- Incidence of Cellular Rejection(6 to 12 months)
- Incidence of Any Treated Rejection(6 to 12 months)
- Number of Participants With Episodes of Rejection Associated With Hemodynamic Compromise (HDC)(6 to 12 months)
- Number of Participants With Development of Angiographically Evident Cardiac Allograft Vasculopathy(1 year)
- Number of Participants With Post-transplant Serious Infections Requiring Intravenous Antimicrobial Therapy(Transplantation through end of study, up to 1 year post transplantation.)
- Number of Participants With Post-transplant Incidence of PTLD(Transplantation through end of study, up to 1 year post transplantation.)
- Post-transplant Safety Outcomes Among Participants: Safety and Tolerability of Rituximab(Transplantation through end of study, up to 1 year post transplantation)