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

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.