A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients

A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.

Inclusion Criteria:

• Age of at least 18 years.
• Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
• Planned creation of a new AVF.

Exclusion Criteria:

• Patients for whom this is the only potential site for an AVF.
• By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch.
• Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent.
• Pregnancy, lactation or plans to become pregnant during the course of the study.