A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)
This trial is active, not recruiting.
|Condition||chronic kidney disease|
|Start date||July 2014|
|End date||December 2016|
|Trial size||300 participants|
|Trial identifier||NCT02110901, PRT-201-310|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Birmingham, AL||University of Alabama at Birmingham||no longer recruiting|
|Phoenix, AZ||AKDHC Medical Research Services , LLC||no longer recruiting|
|Tucson, AZ||AKDHC Medical Research Services, LLc||no longer recruiting|
|Laguna Hills, CA||Alliance Research Center||no longer recruiting|
|Long Beach, CA||VA Medical Center Long Beach||no longer recruiting|
|Los Angeles, CA||Keck University Hospital at USC||no longer recruiting|
|San Diego, CA||Kaiser Permanente Medical Center||no longer recruiting|
|San Diego, CA||California Institute of Renal Research||no longer recruiting|
|San Francisco, CA||UCSF Division of Vascular & Endovascular Surgery||no longer recruiting|
|Chicago, IL||Rush Medical Center||no longer recruiting|
|Peoria, IL||Renal Care Associates||no longer recruiting|
|Fort Wayne, IN||Lutheran Hospital Network of Indiana||no longer recruiting|
|Iowa City, IA||University of Iowa Hospitals and Clinics||no longer recruiting|
|Louisville, KY||University of Louisville||no longer recruiting|
|New Orleans, LA||Tulane University||no longer recruiting|
|Shreveport, LA||Louisiana State University Health Sciences Center||no longer recruiting|
|Portland, ME||Maine Medical Center||no longer recruiting|
|Baltimore, MD||University of Maryland||no longer recruiting|
|Easton, MD||University of Maryland Shore Medical Center at Easton||no longer recruiting|
|Boston, MA||Beth Israel Deaconess Medical Center||no longer recruiting|
|Boston, MA||Brigham and Women's Hospital||no longer recruiting|
|Worcester, MA||University of Massachusetts Medical Center||no longer recruiting|
|New York, NY||Mount Sinai Medical Center||no longer recruiting|
|Chapel Hill, NC||University of North Carolina at Chapel Hill||no longer recruiting|
|Durham, NC||Duke University||no longer recruiting|
|Salisbury, NC||W.G. Hefner VA Medical Center||no longer recruiting|
|Winston-Salem, NC||Wake Forest||no longer recruiting|
|Cincinnati, OH||University of Cincinnati Medical Center||no longer recruiting|
|Cincinnati, OH||University of Cincinnati||no longer recruiting|
|Columbus, OH||Ohio State University||no longer recruiting|
|Tulsa, OK||The University of Oklahoma College of Medicine||no longer recruiting|
|Allentown, PA||Lehigh Valley Health Network||no longer recruiting|
|Pittsburgh, PA||VA Pittsburg Healthcare System||no longer recruiting|
|Houston, TX||The Methodist Hospital||no longer recruiting|
|Bellevue, WA||Lake Washington Vascular Center||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
AVF primary unassisted patency
time frame: 12 months after AVF creation
Secondary AVF patency
time frame: 12 months after AVF creation
Male or female participants from 18 years up to 100 years old.
- 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.
|Official title||Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease|
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