Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Description
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.
Phase
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.Inclusion and Exclusion Criteria
- 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.
Sites
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California
- Keck University Hospital at USC, Los Angeles, California, 90033
- VA Medical Center Long Beach, Long Beach, California, 90822
- California Institute of Renal Research, San Diego, California, 92123
- Kaiser Permanente Medical Center, San Diego, California, 92120
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Arizona
- AKDHC Medical Research Services , LLC, Phoenix, Arizona, 85012
- AKDHC Medical Research Services, LLc, Tucson, Arizona, 85719
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Washington
- Lake Washington Vascular Center, Bellevue, Washington, 98004
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Iowa
- University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242
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Illinois
- Renal Care Associates, Peoria, Illinois, 61603
- Rush Medical Center, Chicago, Illinois, 60612
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Louisiana
- Tulane University, New Orleans, Louisiana, 70112
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Alabama
- University of Alabama at Birmingham, Birmingham, Alabama, 35294
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Indiana
- Lutheran Hospital Network of Indiana, Fort Wayne, Indiana, 46804
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Ohio
- University of Cincinnati, Cincinnati, Ohio, 45267
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