A Prospective, Randomised, Placebo Controlled, Multicenter Study of the Efficacy and Safety of Rituximab as Induction Therapy Together With Tacrolimus, Mycophenolate Mofetil and Steroids for Patients Undergoing Renal Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Composite endpoint of biopsyproven rejection, graft loss or death during the first 6 months following transplanation
研究概览
简要总结
Current strategies for the medical management of transplant patients are largely focused on the prevention and treatment of T-lymphocyte mediated processes. However there is an increasing evidence to suggest that B-lymphocytes have a role in the otherwise classic T-cell mediated rejection of transplants by there ability to act as antigen presenting cells and T-cell activators. Thus there is a significant medical need for effective therapies targeting B cells of transplant patients.One such potential therapy would be to use rituximab, a monoclonal antibody against B-cells in all renal transplant patients. In the present study the efficacy and safety of prophylactic rituximab is studied.
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
- Double
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
- •Patients aged 18 years or above
- •Recipients of first or second renal transplants
- •Recipients of kidneys from living or cadaveric donors
- •Single organ recipients (kidney only)
- •Patients providing written informed consent
- •Patients cooperative and able to complete all the assessment procedures
排除标准
- •Patients receiving other immunosuppressive therapy within the preceding 28 days
- •Recipients of HLA-identical sibling kidneys
- •Patients with flow-PRA >50% within 6 months prior to enrolment
- •Recent history of malignancy
- •Active infection
- •Pregnant or lactating females
- •Women of childbearing potential not willing to use reliable form of contraception
结局指标
主要结局
Composite endpoint of biopsyproven rejection, graft loss or death during the first 6 months following transplanation
次要结局
- Renal function at 6 months
- Incidence of infections
- Incidence of rituximab-related adverse events
- Incidence of malignancies