"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Incidence of Allograft Rejection
研究概览
简要总结
The purpose of the study is to see if campath-1H can be used in first time renal transplant subjects to prevent rejection and reduce the overall amount of anti-rejection medications that patients take on a daily basis.
详细描述
Twenty nine primary recipients of either a live donor or deceased donor renal transplant were enrolled in this study. Subjects were administered two 20mg doses of Campath-1H antibody therapy (Day 0 and Day 1) in combination with a short course of corticosteroids, and maintenance sirolimus.
Subjects were followed for 3 years to compare the incidence and severity of rejection episodes, complications related to the immunosuppression, including infections, malignancies and adverse events. All subjects underwent protocol renal transplant biopsies at 6 and 12 months (unless medically contraindicated).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary renal transplant (not HLA identical)
- •ages 18-60 years
排除标准
- •recipient panel reactive antibody level >10%
- •recipient of a DCD kidney
- •no prior organ transplant
- •no multi-organ transplant recipient
- •no subject who is currently receiving systemic corticosteroids
- •no pregnant or lactating subjects
- •no history of Hepatitis B, C or HIV positivity
- •no recipient of a kidney with cold ischemia time >36 hours
研究组 & 干预措施
Campath 1H induction w/ Sirolimus immunosuppression
Campath 1H at day -1 and 0 of kidney transplant followed by long term CNI free immunosuppressive therapy with Sirolimus,
干预措施: Campath-1H (Drug)
结局指标
主要结局
Incidence of Allograft Rejection
时间窗: 3 years
次要结局
- Patient Survival(3 years)
- Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)(3 years)
- Incidence of Post-transplant Infection(3 years)
- Incidence of Malignancies(3 years)
- Kidney Allograft Survival(3 years)