A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)
- Registration Number
- NCT02110901
- Lead Sponsor
- Proteon Therapeutics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 349
- 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.
- 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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. PRT-201 PRT-201 PRT-201 administered at the time of radiocephalic fistula creation
- Primary Outcome Measures
Name Time Method Kaplan-Meier Estimate of Secondary AVF Patency 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
Louisiana State University Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Keck University Hospital at USC
🇺🇸Los Angeles, California, United States
Rush Medical Center
🇺🇸Chicago, Illinois, United States
Renal Care Associates
🇺🇸Peoria, Illinois, United States
Lutheran Hospital Network of Indiana
🇺🇸Fort Wayne, Indiana, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
AKDHC Medical Research Services , LLC
🇺🇸Phoenix, Arizona, United States
The University of Oklahoma College of Medicine
🇺🇸Tulsa, Oklahoma, United States
Alliance Research Center
🇺🇸Laguna Hills, California, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
VA Medical Center Long Beach
🇺🇸Long Beach, California, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
VA Pittsburg Healthcare System
🇺🇸Pittsburgh, Pennsylvania, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
UCSF Division of Vascular & Endovascular Surgery
🇺🇸San Francisco, California, United States
W.G. Hefner VA Medical Center
🇺🇸Salisbury, North Carolina, United States
University of Maryland Shore Medical Center at Easton
🇺🇸Easton, Maryland, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Kaiser Permanente Medical Center
🇺🇸San Diego, California, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
AKDHC Medical Research Services, LLc
🇺🇸Tucson, Arizona, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
California Institute of Renal Research
🇺🇸San Diego, California, United States
University of Massachusetts Medical Center
🇺🇸Worcester, Massachusetts, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Lake Washington Vascular Center
🇺🇸Bellevue, Washington, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
Wake Forest
🇺🇸Winston-Salem, North Carolina, United States