Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation
Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Living Donor Renal Transplantation - A Study to Evaluate the Avoidance of Long-term Nephrotoxic Calcineurin Inhibitor Therapy
研究概览
详细说明
To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with our standard treatment protocol of Zenapax® and maintenance immunosuppression (vide infra).
To determine the effect different antibody induction regimen on the lymphoid cell subsets of the immune system in kidney allograft recipients peripheral blood and bone marrow aspirates will be tested at surgery before transplantation and at intervals post operatively.
To treat renal transplant patients successfully in the absence of long-term calcineurin inhibition to determine if there are beneficial effects on the prevention of chronic allograft nephropathy.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Florida
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Miami、Florida、美国、33136
- University of Miami Jackson Memorial Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age >14 years
- Weight >40 kg
- Primary renal allograft:living related (non HLA identical) and unrelated donor
- Negative standard cross match for T-cells
- Signed and dated consent form
Exclusion Criteria:
- Patient has previously received or is receiving an organ transplant other than kidney
- Patient has received a kidney transplant from a non-heart beating donor
- Patient has received an ABO incompatible donor kidney
- Recipient or donor is seropositive for human immunodeficiency virus (HIV)
- Patient has a current malignancy or a history of malignancy
学习计划
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：1mg/kg Thymoglobulin
LD kidneys receiving 1mg/kg Thymoglobulin for 7 days starting at the day of surgery.
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comparison of induction therapies.
其他名称：
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有源比较器：Campath-1H at 0.3 mg/kg
Recipients of LD kidneys receiving Campath-1H at 0.3 mg/kg once on the day of surgery and again 3 days post-operatively.
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comparison of induction therapies.
其他名称：
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有源比较器：Zenapax 1 mg/kg
Recipients of LD kidneys receiving Zenapax 1mg/kg on the day of surgery followed by the same dose every 2 weeks for a total of 5 dosages.
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comparison of induction therapies.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor kidneys.
大体时间：3 years
|
3 years
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Patient/graft survival.
大体时间：1 and 3 yrs.
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1 and 3 yrs.
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Incidence of adverse reactions.
大体时间：1 & 3 years.
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1 & 3 years.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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