NCT00679991已完成1 期
A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Proteon Therapeutics11 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 11
- 主要终点
- To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein.
研究概览
简要总结
PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age of at least 18 years.
- •Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
- •Planned creation of a new AVF.
排除标准
- •Patients for whom this is the only potential site for an AVF.
- •By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch.
- •Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent.
- •Pregnancy, lactation or plans to become pregnant during the course of the study.
研究组 & 干预措施
PRT-201
Active Comparator
干预措施: PRT-201 (Drug)
2
Placebo Comparator
干预措施: PRT-201 (Drug)
结局指标
主要结局
To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein.
时间窗: 2 & 6 weeks after AVF creation
次要结局
- The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis.(3, 6, 9, and 12 months)
研究者
研究点 (11)
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