A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT02110901

Run by

Proteon Therapeutics

People needed

349

Starts

2014-07-01

Expected to finish

2018-12-01

Last updated by the study team

2019-07-09

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• AKDHC Medical Research Services , LLC — Phoenix, Arizona, United States
• AKDHC Medical Research Services, LLc — Tucson, Arizona, United States
• Alliance Research Center — Laguna Hills, California, United States
• VA Medical Center Long Beach — Long Beach, California, United States
• Keck University Hospital at USC — Los Angeles, California, United States
• Kaiser Permanente Medical Center — San Diego, California, United States
• California Institute of Renal Research — San Diego, California, United States
• UCSF Division of Vascular & Endovascular Surgery — San Francisco, 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
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Louisville — Louisville, Kentucky, United States
• Tulane University — New Orleans, Louisiana, United States
• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• University of Maryland — Baltimore, Maryland, United States
• University of Maryland Shore Medical Center at Easton — Easton, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Massachusetts Medical Center — Worcester, Massachusetts, United States
• Mount Sinai Medical Center — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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