Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (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
- 696
- 试验地点
- 41
- 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 vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. Vonapanitase 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 vonapanitase 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 CKD.
- •Planned creation of a new radiocephalic 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) or Independent Ethics Committee (IEC).
- •If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit 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 vonapanitase (PRT-201).
- •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
Vonapanitase
Vonapanitase administered at the time of radiocephalic fistula creation
干预措施: Vonapanitase (Drug)
Placebo
Placebo administered at the time of radiocephalic fistula creation
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 to AVF abandonment (secondary patency), assessed up to 1 year.
Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)
Number of Participants With AVF Use for Hemodialysis
时间窗: Assessed at up to 12 Months
AVF use for hemodialysis is defined as the ability of the study AVF to be successfully cannulated and used for hemodialysis for a minimum of 90 days or at least 30 days prior to a patient's last visit, if hemodialysis has not been initiated at least 90 days prior to the patient's last visit. If AVF use is not defined as above, non-use of the AVF for hemodialysis is defined as an abandoned fistula prior to use; or if hemodialysis is recorded on 2 consecutive visits and there is no cannulation date or duration of use is less than 90 days. The patients who are not categorized as having use or non-use of the AVF have insufficient data to determine AVF use for hemodialysis and will be categorized as having indeterminate use.
次要结局
未报告次要终点