NCT01305824已完成2 期
Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Proteon Therapeutics23 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2011年3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
- 发起方
- 入组人数
- 151
- 试验地点
- 23
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability of PRT-201.
研究概览
简要总结
The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.
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
- Quadruple (Participant, Care Provider, 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.
- •Life expectancy of at least 6 months.
- •Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months.
- •Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable.
排除标准
- •History or presence of an arterial aneurysm.
- •Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell cancer, squamous cell skin cancer, or any cancer in situ.
- •Hepatic dysfunction defined as bilirubin, ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal, decompensated cirrhosis, ascites, or known esophageal or gastric varices.
- •Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.
研究组 & 干预措施
PRT 201 (10 micrograms)
Active Comparator
干预措施: PRT-201 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
PRT-201 (30 micrograms)
Active Comparator
干预措施: PRT-201 (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability of PRT-201.
时间窗: 12 months after AVF creation.
Primary AVF patency.
时间窗: 12 months after AVF creation
次要结局
- Secondary Fistula Patency(12 months after AVF creation)
研究者
研究点 (23)
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