Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 349
- 试验地点
- 35
- 主要终点
- Kaplan-Meier Estimate of Secondary AVF Patency
研究概览
简要总结
This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（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.
- •Diagnosis of Chronic Kidney Disease (CKD).
- •Planned creation of a new radiocephalic arteriovenous fistula (AVF)-revision of an existing AVF is not eligible.
- •Ability to understand and comply with the requirements of the entire study and to communicate with the study team.
- •Written informed consent using a document that has been approved by the Institutional Review Board (IRB).
- •If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit (Visit 1) and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra uterine device.
排除标准
- •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 or squamous cell skin cancer, or any cancer in situ.
- •Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
- •Previous treatment with PRT
- •Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent.
研究组 & 干预措施
PRT-201
PRT-201 administered at the time of radiocephalic fistula creation
干预措施: PRT-201 (Drug)
Placebo
Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient.
干预措施: Placebo (Drug)
结局指标
主要结局
Kaplan-Meier Estimate of Secondary AVF Patency
时间窗: Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year
Kaplan-Meier Estimate of median time from AVF creation until AVF abandonment (secondary patency)
Time to AVF Primary Unassisted Patency
时间窗: Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year
Primary unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency.
次要结局
未报告次要终点