A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)
2019年7月20日 更新者：Proteon Therapeutics
Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
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.
研究概览
研究类型
介入性
注册 (实际的)
696
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alberta
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Edmonton、Alberta、加拿大、T6G2B7
- University of Alberta
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British Columbia
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Vancouver、British Columbia、加拿大、V5Z 1M9
- Vancouver General Hospital
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Ontario
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London、Ontario、加拿大、N6A 5W9
- London Health Science Center
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Toronto、Ontario、加拿大、M5G 2C4
- University Health Network Toronto General Hospital
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Quebec
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Montreal、Quebec、加拿大、H4A 3J1
- McGill University Health Centre- Royal Victoria Hospital
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama at Birmingham
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Arizona
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Phoenix、Arizona、美国、85012
- AKDHC Medical Research Services, LLC
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Tucson、Arizona、美国、85724
- Banner University Medical Center Tucson
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Tucson、Arizona、美国、85745
- AKDHC Medical Research Services, LLC
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California
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Loma Linda、California、美国、92357
- VA Loma Linda Healthcare System
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Long Beach、California、美国、90822
- VA Medical Center Long Beach
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Los Angeles、California、美国、90033
- Keck University Hospital at USC
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San Diego、California、美国、92123
- California Institute of Renal Research
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San Diego、California、美国、92120
- Kaiser Permanente
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San Francisco、California、美国、94118
- Kaiser Permanente Northern California
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Illinois
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Chicago、Illinois、美国、60637
- University of Chicago
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Peoria、Illinois、美国、61603
- RenalCare Associates, S.C.
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Indiana
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Fort Wayne、Indiana、美国、46804
- Lutheran Hospital Network of Indiana
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Iowa
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Iowa City、Iowa、美国、52242
- The University of Iowa Hospitals and Clinics
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Kentucky
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Louisville、Kentucky、美国、40202
- University of Louisville
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Louisiana
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New Orleans、Louisiana、美国、70112
- Tulane University
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Maine
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Portland、Maine、美国、04102
- Maine Medical Center
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
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Worcester、Massachusetts、美国、01655
- University of Massachusetts Medical Center
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Michigan
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Ann Arbor、Michigan、美国、48105
- VA Ann Arbor Healthcare System
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Detroit、Michigan、美国、48202
- Henry Ford Hospital
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Mississippi
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Greenwood、Mississippi、美国、38930
- Greenwood Leflore Hospital
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Missouri
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Kansas City、Missouri、美国、64111
- Saint Luke's Hospital
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New York
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New York、New York、美国、10065
- New York Presbyterian Hospital-Weill Cornell Medical Center
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North Carolina
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Chapel Hill、North Carolina、美国、27599
- University of North Carolina at Chapel Hill
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Winston-Salem、North Carolina、美国、27157
- Wake Forest
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic
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Pennsylvania
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Allentown、Pennsylvania、美国、18103
- Lehigh Valley Health Network
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Pittsburgh、Pennsylvania、美国、15240
- VA Pittsburg Healthcare System
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South Carolina
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Orangeburg、South Carolina、美国、29118
- SC Nephrology and Hypertension Center, Inc.
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Tennessee
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Knoxville、Tennessee、美国、37923
- Knoxville Kidney Center
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Texas
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Austin、Texas、美国、78756
- Cardiothoracis and Vascular Surgeons
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Houston、Texas、美国、77030
- The Methodist Hospital
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Houston、Texas、美国、77030
- Baylor College of Medicine
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Washington
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Bellevue、Washington、美国、98004
- Lake Washington Vascular Center
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Wisconsin
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Madison、Wisconsin、美国、53792
- University of Wisconsin School of Medicine and PH
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 100年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Vonapanitase
Vonapanitase administered at the time of radiocephalic fistula creation
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其他名称：
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安慰剂比较：Placebo
Placebo administered at the time of radiocephalic fistula creation
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Kaplan-Meier Estimate of Secondary AVF Patency
大体时间：Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.
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Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)
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Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.
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Number of Participants With AVF Use for Hemodialysis
大体时间：Assessed at up to 12 Months
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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.
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Assessed at up to 12 Months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年8月1日
初级完成 (实际的)
2018年2月1日
研究完成 (实际的)
2019年5月1日
研究注册日期
首次提交
2015年4月8日
首先提交符合 QC 标准的
2015年4月10日
首次发布 (估计)
2015年4月13日
研究记录更新
最后更新发布 (实际的)
2019年8月13日
上次提交的符合 QC 标准的更新
2019年7月20日
最后验证
2019年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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