NCT00719225No Longer Available不适用
Belatacept for Renal Allograft Recipients: A Compassionate Use Program
Bristol-Myers Squibb7 个研究点 分布在 1 个国家开始时间: 2008年7月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 7
研究概览
简要总结
To make belatacept available for recipients of a renal allograft who are currently intolerant to or have contraindications to CNIs and/or m-TOR inhibitors and are either:
- unable to construct an adequate immunosuppression regimen due to nonrenal toxicity / contraindication (and withdrawing the causative agent would lead to renal graft loss) OR
- at imminent risk of losing the allograft kidney due to nephrotoxicity and have no other options for renal replacement therapy
研究设计
- 研究类型
- Expanded Access
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
- •Men and women of age 18 years or older inclusive
- •Recipient of a renal allograft for at least ≥ 2 months
- •EBV positive
- •Unable to tolerate a suitable immunosuppression regimen to prevent acute allograft rejection, due to:
- •Extra-renal toxicity related to CNIs and/or m-TOR inhibitors that is refractory to medical management (eg, uncontrolled seizures)
- •Contraindication to CNIs and/or m-TOR inhibitors
- •At imminent risk of losing allograft kidney due to nephrotoxicity
- •Renal failure: ≥ Stage 4 on KDOQI Scale (GFR 15 - 29 cc/min)
- •And no other renal replacement therapy
- •Subjects must be receiving the maintenance immunosuppressants MMF, MPA, or AZA
排除标准
- •Any significant infection, extra-renal solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplants, with an unresolved episode of AR within the last 6 weeks
- •EBV negative
研究者
研究点 (7)
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