Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Graft Creation in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 16
- 主要终点
- To assess the safety of a single topical dose of PRT-201.
研究概览
简要总结
PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein. The goal of the treatment is to improve primary patency and long-term survival of AVGs and thereby provide patients with chronic kidney disease (CKD) a reliable and durable vascular access site for hemodialysis. Recent data indicate that up to three quarters of patients have loss of graft patency at one year, indicating a substantial need for new therapies. This clinical trial will explore the safety and dilatory effect of topically administered PRT-201 on the outflow vein of a newly placed upper extremity AVG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 3 months or current hemodialysis dependence.
- •Planned creation of a new upper extremity AVG or "jump" graft
排除标准
- •Patients for whom this is the only potential site for an upper extremity vascular access.
- •Creation of a new AVG or "jump" graft in an upper extremity previously treated with an investigational gene or cell based therapy, or locally with an investigational pharmacological agent.
- •On physical examination or by other means, suspected proximal vein stenosis, occlusion, lack of continuity with the subclavian vein, central venous stenosis or central venous occlusion.
- •History or presence of an arterial aneurysm.
- •Previous treatment with PRT-201.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
PRT-201
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.
时间窗: Day of AVG creation and 4 weeks After surgery.
次要结局
- Primary graft patency(3, 6, 9 and 12 months after AVG creation.)
- Secondary graft patency.(3, 6, 9 and 12 months after AVG creation.)