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.
Applied topically to AVF during surgery
Dose escalation study. Drug/placebo administered at the time of fistula creation
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.