跳至主要内容
临床试验/NCT00214266
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

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2005年1月最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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