NCT00807794已完成1 期
Phase I Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- To evaluate the clinical safety of MEDI-507. Each adverse event will be reported by severity grade, relationship to study drug, organ system, and need for medical intervention.
研究概览
简要总结
To evaluate the clinical safety of different doses of MEDI-507 through day 33.
详细描述
To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 allograft recipients receiving their first or second allograft
- •Age over 18
- •Maintained on conventional immunosuppression
- •Completed informed consent document
排除标准
- •Known hypersensitivity to MEDI-507
- •More than two renal allografts
- •Moribund and unlikely (in the opinion of the investigator) to survive the duration of the trial
- •Simultaneous use of other investigational agents (this does not include the use of licensed agents for indications not listed in the package insert)
- •Any of the following clinical settings or diagnoses posttransplant:
- •pregnancy or nursing mother: Ø Human Immunodeficiency Virus infection Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator Ø hyperacute rejection
- •Having received OKT3, tacrolimus, or antilymphocyte globulin during the current allograft
- •Less than 10 ml/hr average urine output over 4 hours since the end of surgery
研究组 & 干预措施
1
Experimental
MEDI-507
干预措施: MEDI-507 (Drug)
2
Experimental
MEDI-507
干预措施: MEDI-507 (Drug)
3
Experimental
MEDI-507
干预措施: MEDI-507 (Drug)
4
Experimental
MEDI-507
干预措施: MEDI-507 (Drug)
5
Experimental
MEDI-507
干预措施: MEDI-507 (Drug)
结局指标
主要结局
To evaluate the clinical safety of MEDI-507. Each adverse event will be reported by severity grade, relationship to study drug, organ system, and need for medical intervention.
时间窗: Day 33
次要结局
- To collect initial pharmacokinetic parameters, the incidence and time to first episode of acute rejection, the number of episodes of rejection and graft survival.(Day 33)
研究者
研究点 (4)
Loading locations...
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