NCT00214266已完成2 期
A Pilot Study of Campath-1H Induction Therapy Combined With CellCept® Therapy to Allow for a Calcineurin Inhibitor Free Regimen After Renal Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- renal allograft function
研究概览
简要总结
The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will obviate the need for long-term calcineurin inhibitors in renal transplantation. Most successful strategies to date have relied on the use of either tacrolimus or cyclosporine. However, the advantage of a calcineurin inhibitor free regimen may include improved renal allograft function, a lower incidence of hypertension, diabetes, and less drug related side effects. This is a non-randomized open-label pilot trial in 30 adult renal transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •renal transplant recipients
排除标准
- •Recipients of HLA-identical living-donor renal transplants;
- •multi-organ transplant;
- •known hypersensitivity to Campath-1H, Rituximab, CellCept, or prednisone;
研究组 & 干预措施
Campath-1H Induction Therapy Combined With CellCept® Therapy
Experimental
Campath-1H Induction Therapy Combined With CellCept® Therapy
干预措施: Campath 1H®, Rituximab, mycophenolate mofetil (Drug)
结局指标
主要结局
renal allograft function
时间窗: 2 years
次要结局
- incidence of hypertension(2 years)
- drug related side effects(2 years)
- incidence of diabetes(2 years)
研究者
研究点 (1)
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