A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Arteriovenous Fistula; Fistula
Intervention: PRT-201; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 349.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: radiocephalic; arteriovenous fistula; AVF; hemodialysis; PRT-201; vascular access; kidney; renal; vonapanitase; PATENCY-1

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age of at least 18 years.

          2. Life expectancy of at least 6 months.

          3. Diagnosis of Chronic Kidney Disease (CKD).

          4. Planned creation of a new radiocephalic arteriovenous fistula (AVF)-revision of an
             existing AVF is not eligible.

          5. Ability to understand and comply with the requirements of the entire study and to
             communicate with the study team.

          6. Written informed consent using a document that has been approved by the Institutional
             Review Board (IRB).

          7. 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.

        Exclusion Criteria:

          1. 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.

          2. Presence of any significant medical condition that might significantly confound the
             collection of safety and efficacy data in this study.

          3. Previous treatment with PRT 201.

          4. Treatment with any investigational drug within the previous 30 days or investigational
             antibody therapy within the previous 90 days prior to signing informed consent.